| Primary Device ID | 00850057346268 |
| NIH Device Record Key | 83893d37-3ebc-482b-9db4-9a64956c2125 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SRI Healthcare |
| Version Model Number | PREMSRGWNXLT04-SV-0MDGN-0XL |
| Catalog Number | 7804 |
| Company DUNS | 825198484 |
| Company Name | Elevate Textiles, Inc. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | true |
| Phone | 13366841683 |
| nathaniel.terry@elevatetextiles.com | |
| Phone | 13366841683 |
| nathaniel.terry@elevatetextiles.com | |
| Phone | 13366841683 |
| nathaniel.terry@elevatetextiles.com | |
| Phone | 13366841683 |
| nathaniel.terry@elevatetextiles.com | |
| Phone | 13366841683 |
| nathaniel.terry@elevatetextiles.com | |
| Phone | 13366841683 |
| nathaniel.terry@elevatetextiles.com | |
| Phone | 13366841683 |
| nathaniel.terry@elevatetextiles.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850057346268 [Primary] |
| FYA | Gown, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850057346268]
Moist Heat or Steam Sterilization
[00850057346268]
Moist Heat or Steam Sterilization
[00850057346268]
Moist Heat or Steam Sterilization
[00850057346268]
Moist Heat or Steam Sterilization
[00850057346268]
Moist Heat or Steam Sterilization
[00850057346268]
Moist Heat or Steam Sterilization
[00850057346268]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-16 |
| Device Publish Date | 2024-04-08 |
| 00850057346329 | Surgical Gown, Level 2, Size S, Green, Reuseable |
| 00850057346220 | Mayo Stand Cover |
| 00850057346213 | Mayo Stand Cover |
| 00850057346206 | Mayo Stand Cover |
| 00850057346190 | BTC070122000-4-SV-0MDGN-000 |
| 00850057346183 | Back Table Cover |
| 00850057346176 | Back Table Cover |
| 00850057346169 | Back Table Cover |
| 00850057346152 | Back Table Cover |
| 00850057346138 | Sheet, Level 4 large |
| 00850057346121 | Sheet, Level 4 medium |
| 00850057346114 | Sheet, Level 4 small |
| 00850057346107 | Drape, Specialty |
| 00850057346084 | Drape, three quarter sheet |
| 00850057346077 | Drape, half sheet |
| 00850057346060 | Drape, one quarter sheet |
| 00850057346008 | Mayo Stand Cover |
| 00850057346299 | Surgical Gown, Level 3, Size L, Green, Reuseable |
| 00850057346145 | Sheet, Level 4 extra large |
| 00850057346091 | Drape, Full Sheet |
| 00850057346367 | Surgical Gown, Level 2, Size 2XL, Green, Reuseable |
| 00850057346350 | Surgical Gown, Level 2, Size XL, Green, Reuseable |
| 00850057346343 | Surgical Gown, Level 2, Size LG, Green, Reuseable |
| 00850057346336 | Surgical Gown, Level 2, Size M, Green, Reuseable |
| 00850057346312 | Surgical Gown, Level 3, Size 2XL, Green, Reuseable |
| 00850057346305 | Surgical Gown, Level 3, Size XL, Green, Reuseable |
| 00850057346282 | Surgical Gown, Level 3, Size M, Green, Reuseable |
| 00850057346275 | Surgical Gown, Level 4, Size 2XL, Green, Reuseable |
| 00850057346268 | Surgical Gown, Level 4, Size XL, Green, Reuseable |
| 00850057346251 | Surgical Gown, Level 4, Size L, Green, Reuseable |
| 00850057346244 | Surgical Gown, Level 4, Size M, Green, Reuseable |
| 00850057346237 | Surgical Gown, Level 4, Size S, Green, Reuseable |
| 00850057346053 | Wrapper, 53 x 72, Size Large, Green |
| 00850057346046 | Wrapper, 54 x 54, Size 2XL, Green |
| 00850057346039 | Wrapper, 48 x 48, Size XL, Green |
| 00850057346022 | Wrapper, 36 x 36, Size Large, Green |
| 00850057346015 | Surgical Gown, Level 3, Size S, Green, Reuseable |