Identity
- Trade Name
- ZOLL-DENTAL FDA UDI
- Generic Name
- Bone graft packing block FDA UDI
- Device Name
- 1.8mm/2.8mm Serrated FDA UDI
- Model / Reference
- GP-1.8/2.8SER FDA UDI
- Description
- 1.8mm/2.8mm Serrated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840105205531 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Bone graft packing block 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone graft packing block
Zoll-Dental by Zoll-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone graft packing block.
- TRYPTIK CC INSTRUMENTATION — Spineart · Class II
- Vu aPod™ - L — SeaSpine Orthopedics Corporation · Class I
- SI-LUTION Sacroiliac Joint Fusion System — Curiteva, LLC · Class II
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- SANTORINI™ Corpectomy Cage System — K2M, INC. · Class I
- Savant Lumbar Interbody Fusion System — Curiteva, LLC · Class II
- PERLA TL — Spineart · Class I
- KODIAK PL TL GRAFT BLOCK — MET 1 TECHNOLOGIES, LLC · 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
- Zoll-Dental
Sources (1)
- FDA UDI 3f4cf0d7-00e4-4e33-be07-f995ed1b48a2 34 fields · synced May 30, 2026