| Primary Device ID | 04260676050099 |
| NIH Device Record Key | 63b3efe3-4299-4d42-8656-8620e50ef3db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rolko |
| Version Model Number | TGN-R100GR-Hr-1-55/60 |
| Company DUNS | 328715693 |
| Company Name | Rolko Kohlgrüber GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260676050082 [Primary] |
| GS1 | 04260676050099 [Package] Contains: 04260676050082 Package: cardboard box [75 Units] In Commercial Distribution |
| ILZ | Accessories, Traction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-13 |
| Device Publish Date | 2023-09-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ROLKO 79275197 not registered Live/Pending |
Rolko Kohlgrüber GmbH 2019-06-28 |