Identity
- Trade Name
- KELLAN BLADE COLLET FDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- KELLAN BLADE COLLET FDA UDI
- Model / Reference
- AE-8005 FDA UDI
- Description
- KELLAN BLADE COLLET FDA UDI
Identifiers
- Catalog Number
- AE-8005 FDA UDI
- Primary DI / UDI-DI
- 00841668141007 FDA UDI
- FDA Product Code
- GDZ FDA UDI
- GMDN Term
- Scalpel handle, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scalpel handle, reusable
Kellan Blade Collet by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel handle, reusable.
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- KNIFE HANDLE — SONTEC INSTRUMENTS, INC. · Class I
- SCALPEL HANDLE #4 — W.H. Holden, Inc. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Brasseler USA — Peter Brasseler Holdings, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Katena Products, Inc.
Sources (1)
- FDA UDI d092417a-ad79-4a61-a8b3-4df90417bdc6 35 fields · synced Jun 12, 2026