Identity
- Trade Name
- KYPHON® EXPRESS™ Bone Biopsy Device FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- BONE BIOPSY DEVICE F07A TAPERED SIZE 2 FDA UDI
- Model / Reference
- F07A FDA UDI
- Description
- BONE BIOPSY DEVICE F07A TAPERED SIZE 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000311704 FDA UDI
- FDA Product Code
- KIH FDA UDI
- GMDN Term
- Bone access cannula 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
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
Category: Bone access cannula
KYPHON® EXPRESS™ Bone Biopsy Device by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone access cannula.
- BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length — Tecres · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Stryker — Provision · Class I
- Omnia Medical PsiF — Omnia Medical · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Omnia Medical Instruments — Omnia Medical · Class I
- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 7bea6390-16df-4b0a-b744-e2e50d6a777a 35 fields · synced May 30, 2026