Identity
- Trade Name
- TITANIUM DEBAKEY NEONATAL CLAMP FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
- Device Name
- TITANIUM DEBAKEY NEONATAL CLAMP REVERSED ANGLED JAW CURVED SHANK FDA UDI
- Model / Reference
- 2605-161B FDA UDI
- Description
- TITANIUM DEBAKEY NEONATAL CLAMP REVERSED ANGLED JAW CURVED SHANK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896005266 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 — 4.75 Inch FDA UDI
Category: Surgical soft-tissue manipulation forceps, scissors-like, reusable
Titanium Debakey Neonatal 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.
- Hayden Medical — Hayden Medical Inc · Class I
- Sklar® — Sklar Corporation · Class I
- 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 4200a336-a31f-4049-85f5-756d64f433f1 36 fields · synced May 30, 2026