| Primary Device ID | 00850015378140 |
| NIH Device Record Key | b2201b2c-f196-4d60-b207-c802aad33605 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exact Medical Manufacturing Inc. |
| Version Model Number | E100350 |
| Catalog Number | E100350 |
| Company DUNS | 014464314 |
| Company Name | EXACT MEDICAL MANUFACTURING, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850015378133 [Primary] |
| GS1 | 00850015378140 [Package] Contains: 00850015378133 Package: Case [36 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 | 2020-02-11 |
| Device Publish Date | 2020-02-03 |
| 00850015378188 | XXL Poly-reinforced Surgical Gown |
| 00850015378164 | XL Poly-reinforced Surgical Gown |
| 00850015378140 | Large Poly-reinforced Surgical Gown |
| 00850015378102 | XL Fabric Reinforced Surgical Gown |
| 00850015378089 | Large Fabric Reinforced Surgical Gown |
| 00850015378065 | XXL AAMI 3 Non-Reinforced Surgical Gowns |
| 00850015378041 | XL AAMI 3 Non-Reinforced Surgical Gown |
| 00850015378027 | Large AAMI 3 Non-Reinforced Surgical Gown |
| 00816953024020 | Microscope Drape, Zeiss MD,117x381cm - 46"x150" |