Identity
- Trade Name
- Sutter FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Bipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.2 x 8.0mm 45° angled down FDA UDI
- Model / Reference
- 780297SGS FDA UDI
- Description
- Bipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.2 x 8.0mm 45° angled down FDA UDI
Identifiers
- Catalog Number
- 780297SGS FDA UDI
- Primary DI / UDI-DI
- ESUM780297SGS0 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
MR Unsafe FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Sutter by Sutter Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
- AESCULAP — AESCULAP, INC. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
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
- Sutter Medizintechnik GmbH
Sources (1)
- FDA UDI 5cfef922-dd9e-4aae-bfc4-7d022ce373dd 35 fields · synced May 31, 2026