Identity
- Trade Name
- ProdiGI FDA UDI
- Generic Name
- Internally-anchored endoscopic retractor FDA UDI
- Device Name
- Traction Wire FDA UDI
- Model / Reference
- ERD-TW35 FDA UDI
- Description
- Traction Wire FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521806870 FDA UDI
- FDA Product Code
- QSW FDA UDI
- GMDN Term
- Internally-anchored endoscopic retractor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4410 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
Dimensions & Sizes
- Size
- Length — 35 Millimeter FDA UDI
Category: Internally-anchored endoscopic retractor
ProdiGI by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internally-anchored endoscopic retractor.
- EndoLift — VIRTUAL PORTS LTD · Class I
- EndoGrab — VIRTUAL PORTS LTD · Class I
- UpLivt — BOEHRINGER LABORATORIES, LLC · Class II
- Mediflex — ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED · Class I
- EndoGrab-Short — VIRTUAL PORTS LTD · Class I
- ProdiGI — Covidien LP · Class II
- ProdiGI — Covidien LP · 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 |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 9f0ed0de-8da6-4db3-9c95-1d8b1d9dc596 36 fields · synced May 30, 2026