Duns Number:832696038
Device Description: C-ARM DRAPE 27 X 17 X 77IN 10/BX
Catalog Number
006.07
Brand Name
V. Mueller
Version/Model Number
006.07
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 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"
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
K902851,K902851
Product Code
HMW
Product Code Name
Drape, microscope, ophthalmic
Public Device Record Key
d8c6ea56-81fa-4742-ad6e-598accc58a51
Public Version Date
February 06, 2020
Public Version Number
5
DI Record Publish Date
October 17, 2017
Package DI Number
20885403133890
Quantity per Package
10
Contains DI Package
10885403133893
Package Discontinue Date
October 01, 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 |