Duns Number:790514756
Device Description: Mini C-arm Drape Kit 46 x 72
Catalog Number
4335-20
Brand Name
OPTICS ONE
Version/Model Number
4335-20
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
2ffdbfbc-69d4-46fe-81e5-30fe2a456d95
Public Version Date
July 23, 2018
Public Version Number
1
DI Record Publish Date
June 21, 2018
Package DI Number
00815384023602
Quantity per Package
10
Contains DI Package
00815384023596
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 123 |