| Primary Device ID | 04049539106018 |
| NIH Device Record Key | 92e5a11f-3b3b-4646-ad79-13bdad844657 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTDRAPE |
| Version Model Number | 306030-0000-000 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049539106001 [Primary] |
| GS1 | 04049539106018 [Package] Contains: 04049539106001 Package: Secondary Package [5 Units] In Commercial Distribution |
| GS1 | 04049539106025 [Package] Package: Tertiary Package [6 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-30 |
| Device Publish Date | 2025-01-22 |
| 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 |