Identity
- Trade Name
- TITANIUM CASTANEDA CLAMP FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
- Device Name
- TITANIUM CASTANEDA CLAMP COOLEY JAWS FDA UDI
- Model / Reference
- 2605-210 FDA UDI
- Description
- TITANIUM CASTANEDA CLAMP COOLEY JAWS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896005327 FDA UDI
- 510(k) Number
- K092544 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 5.25 Inch FDA UDI
Category: Surgical soft-tissue manipulation forceps, scissors-like, reusable
Titanium Castaneda Clamp by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical soft-tissue manipulation forceps, scissors-like, reusable.
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- PILLING — TELEFLEX INCORPORATED · Class II
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class II
- PILLING — TELEFLEX INCORPORATED · Class I
- AESCULAP — AESCULAP, INC. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
Cleared under the same submission
K092544 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 8a74a058-71fd-4974-96b1-26840e02f2a8 36 fields · synced May 31, 2026