| 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 |