Identity
- Trade Name
- Gynex FDA UDI
- Generic Name
- Open-surgery biopsy forceps, reusable FDA UDI
- Model / Reference
- TT007 FDA UDI
Identifiers
- Primary DI / UDI-DI
- GYNXTT0070 FDA UDI
- FDA Product Code
- HFB FDA UDI
- GMDN Term
- Open-surgery biopsy forceps, reusable FDA UDI
Classification
- Device Class
- Class I 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
No
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
Yes
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
Category: Open-surgery biopsy forceps, reusable
Gynex by Gynex Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery biopsy forceps, reusable.
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- ARTHROSCOPIC GRASPING RONGEUR FORCEPS — SONTEC INSTRUMENTS, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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 |
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Manufacturer
- Manufacturer
- Gynex Corporation
Sources (1)
- FDA UDI 1fdaf554-e608-4a0e-a8d5-6b2f02065165 32 fields · synced May 31, 2026