ULTRAPRO UML1

GUDID 10705031085862

Ultrapro MONOCRYL?-PROLENE?-COMPOSITE Poliglecaprone 25/Polypropylene

Johnson & Johnson Medical GmbH

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 10705031085862
• NIH Device Record Key: f86ad86f-1966-4244-a622-07792a7edc28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRAPRO
• Version Model Number: UML1
• Catalog Number: UML1
• Company DUNS: 324368661
• Company Name: Johnson & Johnson Medical GmbH
• 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(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031085862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033337

FDA Product Code

• FTL: Mesh, surgical, polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-21
• Device Publish Date: 2019-01-25

On-Brand Devices [ULTRAPRO]

• 10705031132399: Ultrapro MONOCRYL™-PROLENE™-COMPOSITE Poliglecaprone 25/Polypropylene
• 10705031085862: Ultrapro MONOCRYL?-PROLENE?-COMPOSITE Poliglecaprone 25/Polypropylene