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GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device C2R12

by Applied Medical Resources Corp. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10607915147812 UDI-DIDate22 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
Generic Name
Radial surgical retractor seal cap
Model / Reference
C2R12
Primary DI / UDI-DI
10607915147812
510(k) Number
FDA Product Code
HEW
GMDN Term
Radial surgical retractor seal cap
Device Class
Class II
Regulation Number
884.1640
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No