| Primary Device ID | 29551017622549 |
| NIH Device Record Key | 11163f22-13f0-4aa9-ab06-85cee297096e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROFENCE BLUE BIODEGRADABLE |
| Version Model Number | NITRILE BDGVB35205 |
| Company DUNS | 865807689 |
| Company Name | HARTALEGA NGC SDN. BHD. |
| Device Count | 200 |
| 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09551017622545 [Unit of Use] |
| GS1 | 19551017622542 [Primary] |
| GS1 | 29551017622549 [Package] Contains: 19551017622542 Package: Case [10 Units] In Commercial Distribution |
| LZA | Polymer Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-31 |
| Device Publish Date | 2023-08-23 |
| 29551017622549 | NITRILE BDGVB35205 |
| 29551017622532 | NITRILE BDGVB35204 |
| 29551017622525 | NITRILE BDGVB35203 |
| 29551017622518 | NITRILE BDGVB35202 |
| 29551017622501 | NITRILE BDGVB35201 |