Identity
- Trade Name
- Geistlich Nexo-Gide® FDA UDI
- Generic Name
- Tendon spacer FDA UDI
- Model / Reference
- 500662 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07610221014200 FDA UDI
- FDA Product Code
- FTM FDA UDI
- GMDN Term
- Tendon spacer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 20 Millimeter FDA UDIHeight — 30 Millimeter FDA UDI
Category: Tendon spacer
Geistlich Nexo-Gide® by Geistlich Pharma AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Tenoglide® — Integra Lifesciences Corp. · Class II
- VersaWrap Tendon Protector — ALAFAIR BIOSCIENCES, INC. · Class II
- InSpace™ — ORTHO-SPACE LTD · Class II
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
- Geistlich Pharma AG
Sources (1)
- FDA UDI 5b329ac1-8135-4ed8-882e-c4b113d6d48e 33 fields · synced Jun 6, 2026