| Primary Device ID | 10869653000228 |
| NIH Device Record Key | bbd5ccd0-f59b-448e-be7f-2ac9e61ff428 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 |
| Version Model Number | 2000A-B |
| Catalog Number | 2000A-B |
| Company DUNS | 080180725 |
| Company Name | FLEX OPERATING ROOM, LLC |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 585-635-7260 |
| greg@gerstnermedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869653000221 [Primary] |
| GS1 | 10869653000228 [Package] Contains: 00869653000221 Package: Case [12 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-12-10 |
| Device Publish Date | 2016-09-20 |
| 06975424191761 - Flex Operating Room, LLC | 2023-04-07 Double Wide A-Rack |
| 06975424191778 - Flex Operating Room, LLC | 2023-04-07 Triple Wide Rack |
| 10869653000228 - Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 | 2018-12-10 |
| 10869653000228 - Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 | 2018-12-10 |
| 10869653000235 - Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B8 | 2018-12-10 |
| 10869653000242 - Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A12 | 2018-12-10 |
| 00869653000214 - Dinamic OR Spine Rack Monitor Cover 60x64cm | 2018-03-29 |