| Primary Device ID | 18903389005231 |
| NIH Device Record Key | 99ddfde6-eea4-48c6-8d72-87fa953c3c2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cedrak |
| Version Model Number | Cerdak Aerocloth |
| Company DUNS | 650051832 |
| Company Name | CARBORUNDUM UNIVERSAL LIMITED |
| Device Count | 10 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 3013255574 |
| bupet2015@gmail.com | |
| Phone | 3013255574 |
| bupet2015@gmail.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN DRY PLACE IN ANY AMBIENT TEMPERATURE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN DRY PLACE IN ANY AMBIENT TEMPERATURE |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18903389005231 [Package] Contains: 58903389005239 Package: [10 Units] In Commercial Distribution |
| GS1 | 28903389005238 [Unit of Use] |
| GS1 | 58903389005239 [Primary] |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-18 |
| 58903389005017 - Cerdak | 2018-07-06 Cerdak Basic 30x30mm |
| 18903389005026 - Cerdak | 2018-07-06 Cerdak Basic 50x25mm |
| 18903389005033 - Cerdak | 2018-07-06 Cerdak Basic 50x50mm |
| 18903389005040 - Cerdak | 2018-07-06 Cerdak Basic 50x100mm |
| 18903389005057 - Cerdak | 2018-07-06 Cerdak Basic 45x150mm |
| 18903389005064 - Cerdak | 2018-07-06 Cerdak Basic 45x200mm |
| 18903389005071 - Cerdak | 2018-07-06 Cerdak Basic 45x300mm |
| 18903389005088 - Cerdak | 2018-07-06 Cerdak Basic 100x100mm |