Identity
- Trade Name
- SpineSmith Fusionary Graft Delivery System FDA UDI
- Generic Name
- Bone graft syringe, single-use FDA UDI
- Device Name
- Celling Injection Kit FDA UDI
- Model / Reference
- 0861-0003 FDA UDI
- Description
- Celling Injection Kit FDA UDI
Identifiers
- Catalog Number
- 0861-0003 FDA UDI
- Primary DI / UDI-DI
- 00817771027408 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Bone graft syringe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
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
No
FDA UDI
Category: Bone graft syringe, single-use
SpineSmith Fusionary Graft Delivery System by Celling Biosciences — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone graft syringe, single-use.
- Arthrex® — Arthrex, Inc. · Class II
- I/C Graft Chamber ® — LIFENET HEALTH · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- PRO-DENSE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Celling Biosciences
Sources (1)
- FDA UDI 4b5cccf4-6745-4a6a-8bf4-789aa8dc1eda 35 fields · synced Jun 1, 2026