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Flyte

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
Flyte FDA UDI
Generic Name
Surgical helmet system FDA UDI
Device Name
Charger 120V~ 50-60Hz 1.7A FDA UDI
Model / Reference
0408655000 FDA UDI
Description
Charger 120V~ 50-60Hz 1.7A FDA UDI

Identifiers

Catalog Number
0408655000 FDA UDI
Primary DI / UDI-DI
07613154886289 FDA UDI
FDA Product Code
FXZ FDA UDI
GMDN Term
Surgical helmet system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical helmet system

Flyte by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical helmet system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 7041c505-ee1a-40e2-b4e8-a350b480d25c 36 fields · synced Jun 7, 2026