| Primary Device ID | 84895237141457 |
| NIH Device Record Key | 103987f0-ea60-4830-92c7-4f88e7e936a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOURCE SURGICAL INC. |
| Version Model Number | 1 |
| Catalog Number | 68-2210-W |
| Company DUNS | 686206765 |
| Company Name | KENPAX INTERNATIONAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | 74895237141450 [Primary] |
| GS1 | 84895237141457 [Package] Contains: 74895237141450 Package: case [1000 Units] In Commercial Distribution |
| LYU | Accessory, Surgical Apparel |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-23 |
| Device Publish Date | 2021-03-15 |
| 84895237141471 | Shoe cover A non-sterile device made of a non-conductive material intended to be used as a physi |
| 84895237141464 | Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff |
| 84895237141457 | Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff |