Identity
- Trade Name
- HYDROSET FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- 8GAX10CM TEN CANNULAE PACK FDA UDI
- Model / Reference
- 707001 FDA UDI
- Description
- 8GAX10CM TEN CANNULAE PACK FDA UDI
Identifiers
- Catalog Number
- 707001 FDA UDI
- Primary DI / UDI-DI
- 07613154804788 FDA UDI
- FDA Product Code
- GEA FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 10.0 Centimeter FDA UDINeedle Gauge — 8.0 Gauge FDA UDI
Hydroset by Stryker Leibinger — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Stryker Leibinger
Sources (1)
- FDA UDI 9cc84ff9-5a60-42b2-b04e-af73a660edf5 36 fields · synced Jun 6, 2026