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Flyte 0408635000

by Stryker Corp.

Flyte 0408635000 is a surgical helmet system (FDA Class I; FDA product code FXZ, Helmet, Surgical) made by Stryker Corp., listed in FDA GUDID since 24 Sep 2018 (UDI-DI 04546540591593), 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 Number04546540591593 UDI-DI Date24 Sep 2018ListedStatusListed 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  • Withdrawn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
Flyte
Generic name
Surgical helmet system
Model / Ref / Catalog
0408635000
Primary DI / UDI-DI
04546540591593
FDA product code
FXZ
GMDN term
Surgical helmet system
Device class
Class I
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.68 Kilogram

Related devices

Category: Surgical helmet system

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)