Identity
- Trade Name
- GEN2 FDA UDI
- Generic Name
- Uterine tenaculum FDA UDI
- Device Name
- JACOBS UTERINE VULSELLUM FORCEPS SERR CVD FDA UDI
- Model / Reference
- G2OB1554 FDA UDI
- Description
- JACOBS UTERINE VULSELLUM FORCEPS SERR CVD FDA UDI
Identifiers
- Catalog Number
- G2OB1554 FDA UDI
- Primary DI / UDI-DI
- 00840343713935 FDA UDI
- 510(k) Number
- K092840 FDA UDI
- FDA Product Code
- HCZ FDA UDI
- GMDN Term
- Uterine tenaculum FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 8.25 Inch FDA UDI
Category: Uterine tenaculum
Gen2 by Surgix Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uterine tenaculum.
- Rochester Pean Hemostatic Forceps — CooperSurgical, Inc. · Class I
- ELMED INCORPORATED — ELMED INCORPORATED · Class II
- Hayden Medical — Hayden Medical Inc · Class II
- STILLE Clamps — Stille AB · Class I
- Adler Instrument Company — Adler, Inc. · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- Hayden Medical — Hayden Medical Inc · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Cleared under the same submission
K092840 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
- Surgix Medical Llc
Sources (1)
- FDA UDI 171bf713-4d99-4f95-822b-36b424a2ab48 37 fields · synced May 30, 2026