Identity
- Trade Name
- Luna 3D FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- Luna 3D Accessory Kit FDA UDI
- Model / Reference
- LUN4000 FDA UDI
- Description
- Luna 3D Accessory Kit FDA UDI
Identifiers
- Catalog Number
- LUN4000 FDA UDI
- Primary DI / UDI-DI
- 00813478020377 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone graft delivery kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Orthopaedic inorganic implant inserter/extractor, reusableBone graft delivery kit
Luna 3D by Benvenue Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone graft delivery kit.
- SCP® — Zimmer Knee Creations, Inc. · Class I
- SCP® — Zimmer Knee Creations, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- SCP® PF Foot & Ankle Kit — Zimmer Knee Creations, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- SCP® — Zimmer Knee Creations, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Benvenue Medical, Inc.
Sources (1)
- FDA UDI 3961a219-ada2-42d2-a019-c6bd3d134605 35 fields · synced Jun 8, 2026