Biogel® PI UltraTouch® S Indicator® System

GUDID 07323190240319

Biogel PI UltraTouch S Indicator Underglove 8.5

Mölnlycke Health Care AB

Polyisoprene surgical glove, non-powdered, non-antimicrobial

• Primary Device ID: 07323190240319
• NIH Device Record Key: efce19c1-0306-4d6d-96eb-734b230c7e79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biogel® PI UltraTouch® S Indicator® System
• Version Model Number: 45985
• Company DUNS: 631770658
• Company Name: Mölnlycke Health Care AB
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07323190240319 [Package]; Contains: 07323190240326; Package: CASE [4 Units]; In Commercial Distribution
GS1	07323190240326 [Package]; Contains: 07323190240333; Package: PACK_OR_INNER_PACK [50 Units]; In Commercial Distribution
GS1	07323190240333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190077

FDA Product Code

• KGO: Surgeon's gloves

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-31
• Device Publish Date: 2022-10-21

On-Brand Devices [Biogel® PI UltraTouch® S Indicator® System]

• 07323190240371: Biogel PI UltraTouch S Indicator Underglove 9.0
• 07323190240319: Biogel PI UltraTouch S Indicator Underglove 8.5
• 07323190240265: Biogel PI UltraTouch S Indicator Underglove 8.0
• 07323190240227: Biogel PI UltraTouch S Indicator Underglove 7.5
• 07323190240173: Biogel PI UltraTouch S Indicator Underglove 7.0
• 07323190240111: Biogel PI UltraTouch S Indicator Underglove 6.5
• 07323190240067: Biogel PI UltraTouch S Indicator Underglove 6.0
• 07323190235070: Biogel PI UltraTouch S Indicator Underglove 5.5x50