Identity
- Trade Name
- GEN2 FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, scissors-like, single-use FDA UDI
- Device Name
- LAUFE UTERINE POLY FORCEPS CVD SERR RATCHET 8 1/2" FDA UDI
- Model / Reference
- G2OB1555 FDA UDI
- Description
- LAUFE UTERINE POLY FORCEPS CVD SERR RATCHET 8 1/2" FDA UDI
Identifiers
- Catalog Number
- G2OB1555 FDA UDI
- Primary DI / UDI-DI
- 00840343713942 FDA UDI
- 510(k) Number
- K092840 FDA UDI
- FDA Product Code
- HCZ FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, scissors-like, single-use 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: Surgical soft-tissue manipulation forceps, scissors-like, single-use
Gen2 by Surgix Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical soft-tissue manipulation forceps, scissors-like, single-use.
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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 |
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Manufacturer
- Manufacturer
- Surgix Medical Llc
Sources (1)
- FDA UDI 3fa658ee-d0ec-443a-8c3b-0ec3ca8437c4 37 fields · synced Jun 1, 2026