Identity
- Trade Name
- Tri Cuspid Mitral Valve Retractor FDA UDI
- Generic Name
- Rib spreader, reusable FDA UDI
- Device Name
- Tri Cuspid Mitral Valve Retractor FDA UDI
- Model / Reference
- 2500-325 FDA UDI
- Description
- Tri Cuspid Mitral Valve Retractor FDA UDI
Identifiers
- Catalog Number
- 2500-325 FDA UDI
- Primary DI / UDI-DI
- 00192896120594 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Rib spreader, 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Rib spreader, reusable
Tri Cuspid Mitral Valve Retractor by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rib spreader, reusable.
- PRINCETON — PRINCETON MEDICAL GROUP, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Symmetry Burford-Finochietto — SYMMETRY SURGICAL INC. · Class I
- Gimmi — Gimmi GmbH · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI f41288c1-bc9b-4b30-8294-e57ddca20d13 35 fields · synced May 29, 2026