Flyte, SurgiCool 0408821000

GUDID 37613327117104

Zippered Toga, Large

STRYKER CORPORATION

Surgical gown, single-use

• Primary Device ID: 37613327117104
• NIH Device Record Key: 8415f27a-5066-40b1-bf69-599c2755b948
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flyte, SurgiCool
• Version Model Number: 0408821000
• Catalog Number: 0408821000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327117103 [Primary]
GS1	37613327117104 [Package]; Contains: 07613327117103; Package: pack [9 Units]; In Commercial Distribution

FDA Product Code

• FYA: GOWN, SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Flyte, SurgiCool]

• 37613327117173: Zippered Toga, Peel-Away 3X Large
• 37613327117166: Zippered Toga, 3X Large
• 37613327117159: Zippered Toga, Peel-Away 2X Large
• 37613327117142: Zippered Toga, 2X Large
• 37613327117135: Zippered Toga, Peel-Away X-Large
• 37613327117128: Zippered Toga, X-Large
• 37613327117111: Zippered Toga, Peel-Away Large
• 37613327117104: Zippered Toga, Large
• 37613327117098: Pullover Toga, 3X Large
• 37613327117081: Pullover Toga, 2X Large
• 37613327117074: Pullover Toga, X-Large
• 37613327117067: Pullover Toga, Large
• 37613252661086: Peel-Away Hood
• 37613252661079: Hood