Skip to content

Sterile Drape SD100

by Avinger, Inc.

Sterile Drape SD100 is a Class I device made by Avinger, Inc., listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00851354004264), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851354004264 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sterile Drape
Generic name
Patient surgical drape, single-use
Model / Ref / Catalog
SD100
Primary DI / UDI-DI
00851354004264
FDA product code
KKK
GMDN term
Patient surgical drape, single-use
Device class
Class I
Regulation number
864.1850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Patient surgical drape, single-use

Other devices from Avinger, Inc.

See all devices from Avinger, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)