Identity
- Trade Name
- SONTEC V.A.T.S. ALLIS DEBAKEY CLAMP FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
- Device Name
- SONTEC V.A.T.S. ALLIS DEBAKEY CLAMP CURVED LEFT FDA UDI
- Model / Reference
- 2100-936 FDA UDI
- Description
- SONTEC V.A.T.S. ALLIS DEBAKEY CLAMP CURVED LEFT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896003927 FDA UDI
- 510(k) Number
- K152400 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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 — 13 Inch FDA UDI
Category: Surgical soft-tissue manipulation forceps, scissors-like, reusable
Sontec V.a.t.s. Allis Debakey 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
K152400 also covers:
- HEARTLINE BIOPSY GRASPING FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE COLVIN NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE COOLEY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE CRILEWOOD NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE FLUSHING ADAPTER — SONTEC INSTRUMENTS, INC.
- HEARTLINE JAMESON TENOTOMY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE JAMESON TENOTOMY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE KNOT PUSHER FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE KNOT PUSHER FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE MAYO HEGAR NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE MINI IMA HOLDING FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE MINI JAW NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
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 4b96ee7f-4945-47c8-957d-d86fa786ae56 36 fields · synced May 31, 2026