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IZI Fiber HS116

by Riverpoint Medical LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840277407207 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
IZI Fiber
Generic Name
Polyolefin/fluoropolymer suture, multifilament
Model / Reference
HS116
Primary DI / UDI-DI
00840277407207
FDA Product Code
GAT
GMDN Term
Polyolefin/fluoropolymer suture, multifilament
Device Class
Class II
Regulation Number
878.5000
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Riverpoint Medical LLC

See all devices from Riverpoint Medical LLC →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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