Identity
- Trade Name
- OSTEOCOOL KIT BONE ACCESS 10G 095 FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- KIT OCN004 OSTEOCOOL BONE ACCESS 10G 095 FDA UDI
- Model / Reference
- OCN004 FDA UDI
- Description
- KIT OCN004 OSTEOCOOL BONE ACCESS 10G 095 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000311803 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone access channel 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone access channel kit
Osteocool Kit Bone Access 10g 095 by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone access channel kit.
- Keyfix bone drill 9G — G21 SRL · Class I
- KMC Vertebral Osteotome — Shanghai Kinetic Medical Co., Ltd. · Class I
- Osseoflex® — Merit Medical Systems, Inc. · Class I
- Drill — Shanghai Kinetic Medical Co., Ltd. · Class II
- 0.035" x 5" K-Wire Standard — Trilliant Surgical LLC · Class II
- Cannula — Shanghai Kinetic Medical Co., Ltd. · Class II
- Multifunctional Tool — Shanghai Kinetic Medical Co., Ltd. · Class II
- KMC Guide Wire, 1.6mm, Sharp Tip — Shanghai Kinetic Medical Co., Ltd. · 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 13277ad6-ae7d-4c78-affd-dbbbd9fa0d92 35 fields · synced May 30, 2026