Identity
- Trade Name
- ProdiGI FDA UDI
- Generic Name
- Internally-anchored endoscopic retractor FDA UDI
- Device Name
- Secondary Grasper FDA UDI
- Model / Reference
- ERD-TWSG FDA UDI
- Description
- Secondary Grasper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521808386 FDA UDI
- 510(k) Number
- DEN220006 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
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
Cleared under the same submission
DEN220006 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI 9650e70b-d132-42e0-8cb1-238c83bd4900 36 fields · synced May 30, 2026