Identity
- Trade Name
- Vertebroplasty Injector Kit FDA UDI
- Generic Name
- Orthopaedic cement/bone filler dispensing gun FDA UDI
- Device Name
- Vertebroplasty Set FDA UDI
- Model / Reference
- 49000001 FDA UDI
- Description
- Vertebroplasty Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053175003439 FDA UDI
- FDA Product Code
- OAR FDA UDI
- GMDN Term
- Orthopaedic cement/bone filler dispensing gun FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Orthopaedic cement/bone filler dispensing gun
Vertebroplasty Injector Kit by Adria Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement/bone filler dispensing gun.
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- GUN-01 — Tecres · Class I
- ClearMix Vacuum Mixing System Bone Cement Delivery Gun — Summit Medical, LLC · Class I
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
- Adria Srl
Sources (1)
- FDA UDI c0f3ca57-2e39-4373-b0ba-dfa08df82d12 33 fields · synced Jun 8, 2026