| Primary Device ID | 84895237106036 |
| NIH Device Record Key | aa72b004-1d70-4041-a76e-ec6de5757461 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgi-Plus |
| Version Model Number | 1 |
| Catalog Number | 68-6201-B |
| 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 | 74895237106039 [Primary] |
| GS1 | 84895237106036 [Package] Contains: 74895237106039 Package: Case [5 Units] In Commercial Distribution |
| OEA | Non-Surgical Isolation Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-10 |
| Device Publish Date | 2020-07-02 |
| 04895237100137 | Procedure Mask |
| 74895237109122 | Surgical Mask |
| 04895237102124 | PE Film Gown |
| 84895237109112 | The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel fr |
| 84895237106036 | PE Film Gown |
| 74895237106015 | PE Film Gown |