Identity
- Trade Name
- I/C Graft Chamber ® FDA UDI
- Generic Name
- Bone graft syringe, single-use FDA UDI
- Device Name
- IC Graft Chamber - 15 cc FDA UDI
- Model / Reference
- GDS015T FDA UDI
- Description
- IC Graft Chamber - 15 cc FDA UDI
Identifiers
- Catalog Number
- GDS015T FDA UDI
- Primary DI / UDI-DI
- 00889858395519 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Bone graft syringe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone graft syringe, single-use
I/C Graft Chamber ® by Lifenet Health — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Lifenet Health
Sources (1)
- FDA UDI 57d97bbb-b863-4c0a-87f9-cb128aeef83d 36 fields · synced May 31, 2026