| Primary Device ID | 04049539102416 |
| NIH Device Record Key | 698f97e6-9421-4996-a237-2de0ca88c799 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTDRAPE |
| Version Model Number | 306028-0000-000 |
| Company DUNS | 342228620 |
| Company Name | Carl Zeiss Meditec AG |
| 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049539102386 [Primary] |
| GS1 | 04049539102393 [Package] Contains: 04049539102386 Package: [5 Units] In Commercial Distribution |
| GS1 | 04049539102416 [Package] Contains: 04049539102393 Package: [6 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-04-24 |
| 04049539102416 | 306028-0000-000 |
| 04049539106094 | 306029-0000-000 |
| 04049539106018 | 306030-0000-000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SMARTDRAPE 98779230 not registered Live/Pending |
Nien Made Enterprise Co., Ltd. 2024-09-30 |
![]() SMARTDRAPE 87144584 5586770 Live/Registered |
Carl Zeiss Meditec AG 2016-08-19 |