Primary Device ID | 04049539106094 |
NIH Device Record Key | d0ab4521-24e3-4e35-b801-a507fe894151 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SMARTDRAPE |
Version Model Number | 306029-0000-000 |
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 | 04049539106094 [Primary] |
GS1 | 04049539106100 [Package] Package: secondary package [5 Units] In Commercial Distribution |
GS1 | 04049539106117 [Package] Contains: 04049539106100 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 |