| Primary Device ID | 10620974001918 |
| NIH Device Record Key | 7c10dc81-43ee-4fab-ba9e-88209d105161 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dynamic Tissue Systems™ |
| Version Model Number | CWKSR-L |
| Catalog Number | CWKSR-L |
| Company DUNS | 246848147 |
| Company Name | Southmedic Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10620974001918 [Primary] |
| GZC | Stimulator, neuromuscular, implanted |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-28 |
| Device Publish Date | 2020-12-18 |
| 10620974002342 | ABRA Loop Cannulator |
| 10620974002335 | Cannulator |
| 00620974002321 | ABRA Button Tail |
| 10620974002311 | Elastomer Retainer |
| 00620974002307 | ABRA® Abdominal Wall Closure Set Extension |
| 10620974001932 | Southmedic Surgical Retainer Small |
| 10620974001918 | Southmedic Surgical Retainer Large |
| 10620974001864 | ABRA Silicone Cord Elastomer |
| 10620974001796 | DynaCleft Nasal Elevation System |
| 10620974001789 | DynaCleft Nasal Elevation System |
| 10620974001772 | DynaCleft Bilateral |
| 10620974001765 | DynaCleft Unilateral |
| 10620974001758 | DynaStretch Set |
| 10620974001741 | DynaStretch Set |
| 10620974001734 | DynaClose Set |
| 10620974001727 | DynaClose Set |
| 10620974001710 | SutureSafe Set |
| 10620974001703 | SutureSafe Set |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DYNAMIC TISSUE SYSTEMS 86802236 5505731 Live/Registered |
Southmedic Incorporated 2015-10-28 |