| Primary Device ID | 04260652350137 |
| NIH Device Record Key | d60e8694-7c04-4901-8516-6cbc79d1af2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sleeve heavy-duty4 |
| Version Model Number | SA900 |
| Catalog Number | SA9004H |
| Company DUNS | 341502320 |
| Company Name | Romedis GmbH |
| 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 | 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 | 04260652350137 [Primary] |
| ISS | Prosthesis, Thigh Socket, External Component |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-02 |
| Device Publish Date | 2020-05-25 |
| 04260652350069 - Sleeve Office1 | 2020-06-02 Sleeve to be worn over residual limb/prosthesis socket |
| 04260652350076 - Sleeve Office2 | 2020-06-02 Sleeve worn over residual limb/socket |
| 04260652350083 - Sleeve Office3 | 2020-06-02 |
| 04260652350090 - Sleeve Office4 | 2020-06-02 Sleeve to be worn over residual limb/socket |
| 04260652350106 - Sleeve heavy-duty1 | 2020-06-02 sleeve worn over residual limb/socket |
| 04260652350113 - Sleeve heavy-duty2 | 2020-06-02 sleeve worn over residual limb/socket |
| 04260652350120 - Sleeve heavy-duty3 | 2020-06-02 sleeve worn over residual limb/socket |
| 04260652350137 - Sleeve heavy-duty4 | 2020-06-02sleeve worn over residual limb/socket |
| 04260652350137 - Sleeve heavy-duty4 | 2020-06-02 sleeve worn over residual limb/socket |