Identity
- Trade Name
- GEN2 FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
- Device Name
- COOLEY PEDIATRIC CLAMP, SATINSKY TW 2mm JL 35mm OL 140mm (5 1/2") FDA UDI
- Model / Reference
- G2C62267 FDA UDI
- Description
- COOLEY PEDIATRIC CLAMP, SATINSKY TW 2mm JL 35mm OL 140mm (5 1/2") FDA UDI
Identifiers
- Catalog Number
- G2C62267 FDA UDI
- Primary DI / UDI-DI
- 00840343713089 FDA UDI
- 510(k) Number
- K120492 FDA UDI
- FDA Product Code
- HXD FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 — 5.5 Inch FDA UDIWidth — 2 Millimeter FDA UDI
Category: Surgical soft-tissue manipulation forceps, scissors-like, reusable
Gen2 by Surgix Medical Llc — Class I — 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
K120492 also covers:
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL LLC
- GEN2 — SURGIX MEDICAL 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgix Medical Llc
Sources (1)
- FDA UDI 62a8e56d-fb35-44bb-bf88-087b91845bdd 37 fields · synced Jun 1, 2026