Identity
- Trade Name
- ERBE FDA UDI
- Generic Name
- Syringe dispensing gun, reusable FDA UDI
- Device Name
- ERBELIFT® Hand Pump FDA UDI
- Model / Reference
- 20350-000 FDA UDI
- Description
- ERBELIFT® Hand Pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050147013094 FDA UDI
- FDA Product Code
- FBK FDA UDI
- GMDN Term
- Syringe dispensing gun, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Over-the-Counter
No
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: Syringe dispensing gun, reusable
Erbe by Erbe Elektromedizin GmbH — 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
- Erbe Elektromedizin GmbH
Sources (1)
- FDA UDI 5cd17fbb-8149-42b2-8335-be31b61cc563 34 fields · synced May 30, 2026