TiMESH
GUDID 04042301097576
Ti-Mesh 4" X 6" Light 35 g/m²
pfm medical titanium gmbh
Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable| Primary Device ID | 04042301097576 |
| NIH Device Record Key | 2bb94765-373d-4868-a7b7-3cc6791015af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiMESH |
| Version Model Number | 6000138 |
| Company DUNS | 344675942 |
| Company Name | pfm medical titanium 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04042301097569 [Primary] |
| GS1 | 04042301097576 [Package] Contains: 04042301097569 Package: Box [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031225
FDA Product Code
| OXJ | Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects |
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 | 2019-12-17 |
| Device Publish Date | 2019-12-09 |
On-Brand Devices [TiMESH]
| 04042301144348 | Ti-Mesh 1.4" X 4" Strong 65g/m² |
| 04042301144324 | Ti-Mesh 1.4" X 4" Light 35g/m² |
| 04042301097668 | Ti-Mesh 12" X 12" Light 35g/m² |
| 04042301097651 | Ti-Mesh 6" X 8" Light 35g/m² |
| 04042301097576 | Ti-Mesh 4" X 6" Light 35 g/m² |
| 04042301097552 | Ti-Mesh 4" X 6" Extra Light 16 g/m² |
| 04042301097606 | Ti-Mesh 6" X 6" Light 35g/m² |
Trademark Results [TiMESH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIMESH 75315249 2220142 Dead/Cancelled |
Sofamor Danek Properties, Inc. 1997-06-26 |
 TIMESH 75102736 2047832 Live/Registered |
MEDTRONIC, INC. 1996-05-13 |
 TIMESH 73662837 1492999 Dead/Cancelled |
TIMESH, INC. 1987-05-26 |
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