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EdgeFlow Gel Pad 00274

by EdgeCare Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809887550040 UDI-DIDate12 Jun 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  • Withdrawn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
EdgeFlow Gel Pad
Generic Name
Ultrasound coupling pad
Model / Reference
00274
Primary DI / UDI-DI
08809887550040
510(k) Number
FDA Product Code
MUI
GMDN Term
Ultrasound coupling pad
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
In Commercial Distribution

Other devices from EdgeCare Inc.

See all devices from EdgeCare Inc. →

Properties

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

Other properties (9)

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