| Primary Device ID | 18809802640631 |
| NIH Device Record Key | 2bb49a35-eea6-4c32-9b37-a8d015d63ff2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4 chamber extension zipper |
| Version Model Number | 4ELGX01 |
| Company DUNS | 688817949 |
| Company Name | DAESUNG MAREF CO.,LTD. |
| 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 | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809802640634 [Primary] |
| GS1 | 18809802640631 [Package] Contains: 08809802640634 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 28809802640638 [Package] Contains: 08809802640634 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 38809802640635 [Package] Contains: 08809802640634 Package: Box [20 Units] In Commercial Distribution |
| GS1 | 48809802640632 [Package] Contains: 08809802640634 Package: Box [50 Units] In Commercial Distribution |
| IRP | Massager, Powered Inflatable Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
| 18809802640662 | CENTER BODY EXTENSION ZIPPER 2ea [One polybag] |
| 18809802640655 | ARM EXTENSION ZIPPER 1ea [One polybag] |
| 18809802640648 | LEG EXTENSION ZIPPER XXLarge 2ea [One polybag] |
| 18809802640631 | LEG EXTENSION ZIPPER XLarge 2ea [One polybag] |
| 18809802640624 | LEG EXTENSION ZIPPER Large 2ea [One polybag] |