Identity
- Trade Name
- FlexPro® PenMate® FDA UDI
- Generic Name
- Subcutaneous self-injection aid FDA UDI
- Device Name
- Auto-insertion accessory only for Norditropin® FlexPro® 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL prefilled pens. Designed and intended for use with Novo Nordisk® disposable needles. FDA UDI
- Model / Reference
- 771290 FDA UDI
- Description
- Auto-insertion accessory only for Norditropin® FlexPro® 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL prefilled pens. Designed and intended for use with Novo Nordisk® disposable needles. FDA UDI
Identifiers
- Catalog Number
- 771290 FDA UDI
- Primary DI / UDI-DI
- 00301697712901 FDA UDI
- FDA Product Code
- KZH FDA UDI
- GMDN Term
- Subcutaneous self-injection aid FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Subcutaneous self-injection aid
FlexPro® PenMate® by Novo Nordisk Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Novo Nordisk Inc.
Sources (1)
- FDA UDI e52a5768-e015-410a-83db-0a5736facc01 35 fields · synced Jun 1, 2026