Biogel® PI UltraTouch®

GUDID 07332551892371

Biogel PI UltraTouch M 6.5x50

Mölnlycke Health Care AB

Polyisoprene surgical glove, non-powdered, non-antimicrobial

• Primary Device ID: 07332551892371
• NIH Device Record Key: 00ec736f-c494-4e37-acc7-6e8256158b41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biogel® PI UltraTouch®
• Version Model Number: 42665
• 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
• 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
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• 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
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• Device Size Text, specify: 0
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• 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	07332551892371 [Package]; Contains: 07332551892388; Package: CASE [4 Units]; In Commercial Distribution
GS1	07332551892388 [Package]; Contains: 07332551892395; Package: PACK_OR_INNER_PACK [50 Units]; In Commercial Distribution
GS1	07332551892395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050184

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®]

• 07332551892517: Biogel PI UltraTouch M 5.5x50
• 07332551892449: Biogel PI UltraTouch M 6.0x50
• 07332551892371: Biogel PI UltraTouch M 6.5x50
• 07332551892234: Biogel PI UltraTouch M 7.5x50
• 07332551892173: Biogel PI UltraTouch M 8.0x50
• 07332551892104: Biogel PI UltraTouch M 8.5x50
• 07332551892012: Biogel PI UltraTouch M 9.0x40
• 07332551889869: Biogel PI UltraTouch G 9.0x40
• 07332551889784: Biogel PI UltraTouch G 8.5x50
• 07332551889715: Biogel PI UltraTouch G 8.0x50
• 07332551889654: Biogel PI UltraTouch G 7.5x50
• 07332551889579: Biogel PI UltraTouch G 7.0x50
• 07332551889449: Biogel PI UltraTouch G 6.0x50
• 07332551889364: Biogel PI UltraTouch G 5.5x50
• 07332551184926: Biogel PI UltraTouch 9.0 x40 US
• 07332551184865: Biogel PI UltraTouch 8.5 x50 US
• 07332551184810: Biogel PI UltraTouch 8.0 x50 US
• 07332551184766: Biogel PI UltraTouch 7.5 x50 US
• 07332551184711: Biogel PI UltraTouch 7.0 x50 US
• 07332551184674: Biogel PI UltraTouch 6.5 x50 US
• 07332551184612: Biogel PI UltraTouch 6.0 x50 US
• 07332551184575: Biogel PI UltraTouch 5.5 x50 US
• 07332551892319: Biogel PI UltraTouch M 7.0x50
• 07332551889500: Biogel PI UltraTouch G 6.5x50