Identity
- Trade Name
- BLUE BIPOLAR HARDY BAYONET FORCEPS FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- BLUE BIPOLAR HARDY BAYONET FORCEPS IRRIGATED STOP FDA UDI
- Model / Reference
- 2700-960 FDA UDI
- Description
- BLUE BIPOLAR HARDY BAYONET FORCEPS IRRIGATED STOP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896006560 FDA UDI
- 510(k) Number
- K101080 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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 — 8.5 Inch FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Blue Bipolar Hardy Bayonet Forceps by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class II
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- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- V. Mueller — STERIS CORPORATION · Class II
Cleared under the same submission
K101080 also covers:
- BIPOLAR BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR COAPTATION FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR HARDY BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR HARDY FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR JENSEN BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR JENSEN BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR JEWELERS FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR YASARGIL BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BLACK BIPOLAR BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BLACK BIPOLAR BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BLACK BIPOLAR BAYONET WIDE GRIP FORCEPS — SONTEC INSTRUMENTS, INC.
- BLACK BIPOLAR BAYONET WIDE GRIP FORCEPS — 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 |
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Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 26d1964d-8674-4bb7-b214-8ad3e6f20e41 36 fields · synced Jun 1, 2026