Identity
- Trade Name
- Flyte FDA UDI
- Generic Name
- Surgical helmet system FDA UDI
- Device Name
- Helmet with Fiber Optic Headlight FDA UDI
- Model / Reference
- 0408635000 FDA UDI
- Description
- Helmet with Fiber Optic Headlight FDA UDI
Identifiers
- Catalog Number
- 0408635000 FDA UDI
- Primary DI / UDI-DI
- 04546540591593 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
Dimensions & Sizes
- Size
- Weight — 0.68 Kilogram 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.
- ProneView — DUPACO, INC. · Class I
- TotalShield® II Zippered Surgical Toga, Large — Zimmer Orthopaedic Surgical Products · Class II
- TotalShield® II Zippered Surgical Toga, XL — Zimmer Orthopaedic Surgical Products · Class II
- TOTALSHIELD® II — Zimmer Orthopaedic Surgical Products · Class II
- TOTALSHIELD® II — Zimmer Orthopaedic Surgical Products · Class II
- ProneView — DUPACO, INC. · Class I
- TOTALSHIELD® — Zimmer Orthopaedic Surgical Products · Class II
- TOTALSHIELD® — Zimmer Orthopaedic Surgical Products · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI b2687dce-241a-4b13-a945-6c159bbc6da2 37 fields · synced Jun 7, 2026