| Primary Device ID | 10849296005606 |
| NIH Device Record Key | 317b6073-64bd-4f55-ba63-4bdfb63c81a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 280-012 |
| Company DUNS | 828213426 |
| Company Name | WELMED 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849296005609 [Primary] |
| GS1 | 10849296005606 [Package] Contains: 00849296005609 Package: [20 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
[10849296005606]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2017-06-14 |
| 00849296000574 - NA | 2019-10-23 |
| 00849296005258 - NA | 2019-10-23 |
| 10849296007396 - NA | 2019-10-23 |
| 00849296000017 - NA | 2018-11-08 |
| 10849296000090 - NA | 2018-11-08 |
| 10849296000106 - NA | 2018-11-08 |
| 10849296000113 - NA | 2018-11-08 |
| 10849296000663 - NA | 2018-11-08 |