Biogel® Surgeons

GUDID 05060097931149

Biogel Surgeons 8.5 x 50 US

Mölnlycke Health Care AB

Hevea-latex surgical glove, non-powdered, non-antimicrobial

• Primary Device ID: 05060097931149
• NIH Device Record Key: 9690ba94-da91-4e5d-8685-8e808e7d5ed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biogel® Surgeons
• Version Model Number: 30485
• 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: true
• 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
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	05060097930906 [Primary]
GS1	05060097930982 [Package]; Contains: 05060097930906; Package: PACK_OR_INNER_PACK [50 Units]; In Commercial Distribution
GS1	05060097931149 [Package]; Contains: 05060097930982; Package: CASE [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053441

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® Surgeons]

• 05060097930999: Biogel Surgeons 9.0 x 40 US
• 05060097931149: Biogel Surgeons 8.5 x 50 US
• 05060097931132: Biogel Surgeons 8.0 x 50 US
• 05060097930968: Biogel Surgeons 7.5 x 50 US
• 05060097931118: Biogel Surgeons 7.0 x 50 US
• 05060097931101: Biogel Surgeons 6.5 x 50 US
• 05060097930937: Biogel Surgeons 6.0 x 50 US
• 05060097930920: Biogel Surgeons 5.5 x 50 US