Duns Number:832696038
Device Description: V. Mueller ENDOLAP X-RAY CASSETTE DRAPE 24X24IN
Catalog Number
006.08
Brand Name
V. Mueller
Version/Model Number
006.08
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HMW
Product Code Name
Drape, microscope, ophthalmic
Public Device Record Key
e231e4f7-0b0f-43b4-99f7-c838a44ba4e0
Public Version Date
March 04, 2022
Public Version Number
6
DI Record Publish Date
October 17, 2017
Package DI Number
20885403067607
Quantity per Package
25
Contains DI Package
10885403067600
Package Discontinue Date
January 07, 2021
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 |