X-Repair Z009

GUDID B055009

X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 43mm (WxL)

SYNTHASOME, INC.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: B055009
• NIH Device Record Key: b2df17bd-ab64-41eb-a85c-ebbea7eb630a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Repair
• Version Model Number: Z009
• Catalog Number: Z009
• Company DUNS: 140697280
• Company Name: SYNTHASOME, INC.
• 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: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx
• Phone: 858-490-9400
• Email: xxx@xx.xx

Device Dimensions

• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter
• Width: 25 Millimeter
• Length: 43 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B055009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141394

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-03

On-Brand Devices [X-Repair]

• B05500930: X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 30mm (WxL)
• B055009: X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 43mm (WxL)
• B05501035: X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 35mm (WxL)
• B05501030: X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 30mm (WxL)
• B055010: X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 43mm (WxL)
• B05500935: X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 35mm (WxL)
• B05500925: X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 25mm (WxL)
• B055008: X-Repair, Bioabsorbable surgical mesh, double-layer 12mm x 43mm (WxL)