| Primary Device ID | 00850053354687 |
| NIH Device Record Key | 0c9692dd-fe6e-441e-9a9b-59f8a65c7aa0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POSS Medical |
| Version Model Number | E104170 |
| Company DUNS | 066882769 |
| Company Name | Poss, 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 | true |
| 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 | 00850053354670 [Primary] |
| GS1 | 00850053354687 [Package] Contains: 00850053354670 Package: CASE [40 Units] In Commercial Distribution |
| FYA | Gown, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-10 |
| Device Publish Date | 2025-02-01 |
| 00850053354687 | POSS Medical Sterile AAMI Lvl 4 Surgical Soft Gown XL, Full Reinforcement |
| 00850053354748 | POSS Medical Sterile AAMI Lvl 3 Surgical Soft Gown 2XL, Reinforced |
| 00850053354724 | POSS Medical Sterile AAMI Lvl 3 Surgical Soft Gown XL, Reinforced |
| 00850053354694 | POSS Medical Sterile AAMI Lvl 3 Surgical Soft Gown Large, Reinforced |