| Primary Device ID | 00850015378218 |
| NIH Device Record Key | 11200b53-4f09-4827-998e-baf71f84bd32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Customed |
| Version Model Number | 1006617 |
| Catalog Number | 1006617 |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850015378195 [Primary] |
| GS1 | 00850015378201 [Package] Contains: 00850015378195 Package: Inner Case [10 Units] In Commercial Distribution |
| GS1 | 00850015378218 [Package] Contains: 00850015378201 Package: Case [1 Units] In Commercial Distribution |
| KKX | Drape, 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 | 2020-02-13 |
| Device Publish Date | 2020-02-05 |
| 10850003355150 | Probe Cover, PE, Gel and Elastic bands 15x244cm - 6"x96" |
| 10850003355143 | C-Arm Drape 104x188cm - 41"x74" |
| 10850003355136 | C-Arm Drape 104x163cm - 41"x64" |
| 10850003355129 | Probe Cover, PE, Elastic bands 15x244cm - 6"x96" |
| 10850003355112 | Camera Drape, Blue Elastic Tip, 23x244cm - 9"x96" |
| 00850003355108 | Microscope Drape, Zeiss MD, 137x381cm - 54"x150" |
| 00850003355085 | 9004820 |
| 10850003355075 | Band Bag with tape 102x102cm - 40"x40" |
| 00850003355061 | Microscope Drape, Leica, 104x267cm - 41x105" |
| 00850003355986 | Probe Cover, PE, Gel and Elastic bands 15x244cm, 6"x96" |
| 00850015378218 | Microscope Drape- Leica 137x305cm - 54"x120" |