Duns Number:080284658
Device Description: Microscope Drape 40.5" X 105" (ZO1000T)
Catalog Number
-
Brand Name
Sterimed
Version/Model Number
ZO1000T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IZI
Product Code Name
System, X-Ray, Angiographic
Public Device Record Key
3daad858-4eed-4703-be49-aa7c082a0bd1
Public Version Date
February 06, 2020
Public Version Number
5
DI Record Publish Date
September 18, 2017
Package DI Number
20867878000457
Quantity per Package
8
Contains DI Package
10867878000450
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 108 |