| Primary Device ID | 84895237141198 |
| NIH Device Record Key | aef40459-f15a-4217-b318-b90690a94bce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CustoMed |
| Version Model Number | 1 |
| Catalog Number | 100780 |
| Company DUNS | 686206765 |
| Company Name | KENPAX INTERNATIONAL LIMITED |
| 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 | 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 | 04895237141192 [Primary] |
| GS1 | 84895237141198 [Package] Contains: 04895237141192 Package: CASE [30 Units] In Commercial Distribution |
| FYA | Gown, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-24 |
| Device Publish Date | 2020-07-16 |
| 84895237141105 | Lab coat |
| 84895237141099 | Lab coat |
| 84895237141082 | Lab coat |
| 84895237141075 | Lab coat |
| 84895237141068 | Lab coat |
| 84895237141051 | Lab coat |
| 74895237141047 | Lab coat |
| 74895237141030 | Lab coat |
| 84895237141150 | Surgical cap A non-sterile head covering designed as a cap intended to be worn by surgical staff |
| 84895237141143 | Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff |
| 84895237141136 | Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff |
| 74895237104127 | Shoe cover A non-sterile device made of a non-conductive material intended to be used as a phys |
| 84895237141112 | Shoe cover A non-sterile device made of a non-conductive material intended to be used as a physi |
| 84895237141228 | GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic materials intende |
| 84895237141211 | GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic materials intende |
| 84895237141204 | Gown Reinforced Chest & Sleeve A garment made of natural and/or synthetic materials intended to |
| 84895237141198 | Gown No Reinforced |
| 84895237141181 | Gown Reinforced Chest & Sleeve |
| 84895237141174 | Gown Reinforced Chest & Sleeve |
| 84895237141167 | Gown Reinforced Chest & Sleeve |