Biogel PI Indicator® Underglove

GUDID 07323190097104

Biogel PI Indicator System 5.5 2 x 25

Mölnlycke Health Care AB

Polyisoprene surgical glove, non-powdered, non-antimicrobial

• Primary Device ID: 07323190097104
• NIH Device Record Key: 799781d6-0829-4690-ad67-aa1abb364039
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biogel PI Indicator® Underglove
• Version Model Number: 41455
• Company DUNS: 631770658
• Company Name: Mölnlycke Health Care AB
• 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: 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
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07323190097098 [Package]; Package: CASE [4 Units]; In Commercial Distribution
GS1	07323190097104 [Package]; Contains: 07323190196043; Package: PACK_OR_INNER_PACK [25 Units]; In Commercial Distribution
GS1	07323190196043 [Primary]

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: 2023-04-03
• Device Publish Date: 2023-03-24

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• 07323190097289: Biogel PI Indicator System 8.5 2 x 25
• 07323190097241: Biogel PI Indicator System 8.0 2 x 25
• 07323190097210: Biogel PI Indicator System 7.5 2 x 25
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• 07323190097166: Biogel PI Indicator System 6.5 2 x 25
• 07323190097128: Biogel PI Indicator system 6.0 2 x 25
• 07323190097104: Biogel PI Indicator System 5.5 2 x 25