Identity
- Trade Name
- Gynex FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Device Name
- Insufflation Set Smoke Evacutor FDA UDI
- Model / Reference
- GYN SE8200 FDA UDI
- Description
- Insufflation Set Smoke Evacutor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850003294841 FDA UDI
- FDA Product Code
- FCZ FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic insufflation tubing set, single-use
Gynex by JosNoe Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic insufflation tubing set, single-use.
- Suction Tube — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- Clean Connecting Tube — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- Air/Water Bottle Tubing — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class II
- ERBEFLO CleverCap® — Erbe Medical, LLC · Class II
- ENDO SMARTCAP — MEDIVATORS INC. · Class II
- ENDO SMARTCAP — MEDIVATORS INC. · Class II
- MediChoice — OWENS & MINOR DISTRIBUTION, 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
- JosNoe Medical Inc
Sources (1)
- FDA UDI 8b7bd6c0-b2c0-4ced-8624-9e1ce43d3009 33 fields · synced May 30, 2026