Duns Number:832696038
Device Description: ENDOWRAP CAMERA DRAPE 20/BX
Catalog Number
006.00
Brand Name
V. Mueller
Version/Model Number
006.00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 09, 2018
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MMP
Product Code Name
Cover, barrier, protective
Public Device Record Key
afd722b9-ed65-45df-b2e5-5b1068e55072
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
20885403067416
Quantity per Package
20
Contains DI Package
10885403067419
Package Discontinue Date
January 09, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |