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Camera sleeve PS3901

by Purple Surgical International Limited

Camera sleeve PS3901 is a Class I device made by Purple Surgical International Limited, listed in FDA GUDID since 16 Nov 2017 (UDI-DI 15051223029202), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15051223029202 UDI-DI Date16 Nov 2017ListedStatusListed 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  • Withdrawn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
Camera sleeve
Generic name
Camera cover, single-use
Model / Ref / Catalog
PS3901
Primary DI / UDI-DI
15051223029202
FDA product code
KQM
GMDN term
Camera cover, single-use
Device class
Class I
Regulation number
878.4160
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KQM (Camera, Surgical And Accessories).

Other devices from Purple Surgical International Limited

See all devices from Purple Surgical International Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)