Identity
- Trade Name
- Kiva FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- Kiva VCF Treatment System, First Fracture, Left FDA UDI
- Model / Reference
- FRS2200 FDA UDI
- Description
- Kiva VCF Treatment System, First Fracture, Left FDA UDI
Identifiers
- Catalog Number
- FRS2200 FDA UDI
- Primary DI / UDI-DI
- 00813478020056 FDA UDI
- FDA Product Code
- LOD FDA UDINDN FDA UDI
- GMDN Term
- Orthopaedic cement, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic cement, non-antimicrobial
Kiva by Benvenue Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement, non-antimicrobial.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- OSTEOPAL® — Heraeus Medical LLC · Class II
- Osteo-site Bone Filler Kit-MV — IZI MEDICAL PRODUCTS LLC · Class II
- SMARTSET — DEPUY (IRELAND) · Class II
- Montage Settable Bone Putty — ABYRX, INC. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- SMARTSET — DEPUY (IRELAND) · Class II
- OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSAL — SURGENTEC 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Benvenue Medical, Inc.
Sources (1)
- FDA UDI 3e9688b9-9582-4aca-a13a-096582d74752 35 fields · synced Jun 8, 2026