Laboratory & Healthcare Identification
LH-09
Medical Device UDI Labels
This product is intended for medical-device regulatory, quality, packaging, UDI-data and manufacturing-engineering teams.
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Product overview
What this product covers
This product is intended for medical-device regulatory, quality, packaging, UDI-data and manufacturing-engineering teams. The label applies customer-approved UDI, product and production identifiers to device or pack and links them to database and controlled artwork revision. The customer defines applicable UDI rule, carrier and data before size, code quality, material, application and reading are validated. This product is designed to link medical devices to product records through a UDI machine-readable code. Material, dimensions, artwork, data and installation are selected for the actual project. This page presents one standard model, LH-09, in Durable polyester label stock. Dimensions, processes and acceptance notes on this page refer to this representative construction.
Applications
- UDI identification on medical devices and packaging
Buyers and teams
- medical-device regulatory, quality, packaging, UDI-data and manufacturing-engineering teams
Materials
- Durable polyester label stock
Marking
- Custom to artwork
Installation
- Designed for the mounting object
Specifications
| Field | Documented value |
|---|---|
| UDI carrier size | Label width × height, machine-readable area, human-readable area and quiet zone |
| Data & revision | Customer-approved identifiers, symbology, data structure, revision and data owner |
| Application surface | Device/pack material, curvature, roughness and label position |
| Process exposure | Cleaning, disinfection, sterilisation, temperature, humidity, abrasion and service life |
| Verification | Scanner, distance, orientation, minimum accepted grade and sampling plan |
Recommended project inputs
- Medical Device UDI Labels; market and rule, DI/PI data, approved artwork, device or pack substrate, scanner, quantity and validation.
- State the identified object, material/surface, available space, orientation, holes/ties/adhesive/matched tool and provide a site photo where possible.
- Provide length, width/diameter, thickness, corners/edges, holes/slots, fit tolerances and any keep-clear or no-adhesive zones.
- Supply final text, units, graphics, colour, language, serial/barcode/RFID rule, human-readable data and one approved revision; numbers shown in sample images are never treated as production data.
- State temperature and dwell, indoor/outdoor use, UV, water, oil, cleaner/chemical, abrasion, vibration, read conditions or other real exposure together with test method and pass/fail criterion.
- Provide prototype and production quantity, start/end and permitted-gap rules, grouping, packing sequence, batch documents and target delivery.
- Where regulation, certification, permit, ethics, brand authorisation or customer specification applies, provide the applicable revision and owner-approved file; a product name or image cannot replace it.
Continue with this product
Discuss Medical Device UDI Labels
Include product code LH-09 with the project inputs that apply.