Flyte 0408645000

GUDID 04546540591609

Helmet with Battery Powered Headlight

STRYKER CORPORATION

Surgical helmet system

• Primary Device ID: 04546540591609
• NIH Device Record Key: 1a5e0ce8-924a-4bce-9c6c-e2a9b96d9214
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flyte
• Version Model Number: 0408645000
• Catalog Number: 0408645000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com

Device Dimensions

• Weight: 0.52 Kilogram

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540591609 [Primary]

FDA Product Code

• FXZ: HELMET, SURGICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-25
• Device Publish Date: 2018-09-24

On-Brand Devices [Flyte]

• 37613252463093: Peel-Away Hood with Blue Wrap
• 37613252457085: Hood, Peel-Away
• 37613252457078: Hood
• 37613154891208: Zippered Toga, 3X Large
• 37613154891116: Pullover Toga, 3X Large
• 07613154891061: Charger 230V~ 50-60Hz 0.9A
• 37613154886334: Peel-Away Toga, 3X Large
• 07613154886289: Charger 120V~ 50-60Hz 1.7A
• 04546540592675: Power Cord Dictation
• 34546540591853: Peel-Away Toga, 2X Large
• 34546540591846: Zippered Toga, 2X Large
• 34546540591822: Peel-Away Toga, X-Large
• 34546540591815: Zippered Toga, X-Large
• 34546540591792: Toga, Peel-Away Large
• 34546540591785: Zippered Toga, Large
• 34546540591723: Hood, Peel-Away
• 34546540591716: Hood
• 34546540591693: Pullover Toga, 2X Large
• 34546540591686: Pullover Toga, X-Large
• 34546540591679: Pullover Toga, Large
• 04546540591647: Charger Module
• 04546540591630: Charger Software Upgrade Kit
• 04546540591623: Charger 100V~ 50-60Hz 1.9A
• 04546540591609: Helmet with Battery Powered Headlight
• 04546540591593: Helmet with Fiber Optic Headlight
• 04546540591586: Power Cord
• 04546540591579: Helmet
• 34546540591563: Comfort Pad Sets
• 37613327514064: Hood
• 37613327514057: Zippered Toga, X-Large
• 37613327520270: Hood, S95