| Primary Device ID | 00850057346381 |
| NIH Device Record Key | f0044cbd-2fa6-4298-8a19-9cf9410f5b07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Burlington Industries |
| Version Model Number | SURGWNMAXULT03-SV-0115F-0MD |
| Catalog Number | 7902 |
| 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 | 00850057346381 [Primary] |
| FYA | Gown, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850057346381]
Moist Heat or Steam Sterilization
[00850057346381]
Moist Heat or Steam Sterilization
[00850057346381]
Moist Heat or Steam Sterilization
[00850057346381]
Moist Heat or Steam Sterilization
[00850057346381]
Moist Heat or Steam Sterilization
[00850057346381]
Moist Heat or Steam Sterilization
[00850057346381]
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 |
| 00850057346404 | Surgical Gown, Level 3, Size XL, Blue, Reuseable |
| 00850057346398 | Surgical Gown, Level 3, Size L, Blue, Reuseable |
| 00850057346374 | Surgical Gown, Level 3, Size S, Blue, Reuseable |
| 00850057346411 | Surgical Gown, Level 3, Size 2XL, Blue, Reuseable |
| 00850057346381 | Surgical Gown, Level 3, Size M, Blue, Reuseable |