X-Repair Z008
GUDID B055008
X-Repair, Bioabsorbable surgical mesh, double-layer 12mm x 43mm (WxL)
SYNTHASOME, INC.
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable| Primary Device ID | B055008 |
| NIH Device Record Key | bd2a67af-7c6b-442e-ba86-9a6c05e279c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-Repair |
| Version Model Number | Z008 |
| Catalog Number | Z008 |
| 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 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com | |
| Phone | 858-490-9400 |
| info@synthasome.com |
Device Dimensions
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
| Width | 12 Millimeter |
| Length | 43 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B055008 [Primary] |
FDA Product Code
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon |
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 | 2023-08-01 |
| Device Publish Date | 2023-07-24 |
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) |
Trademark Results [X-Repair]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 X-REPAIR 78740382 3716984 Live/Registered |
Synthasome, Inc. 2005-10-25 |
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