Duns Number:021628771
Device Description: OB/GYN FILTER PACK, COOPER, PACK/3. Medical Device.
Catalog Number
72102
Brand Name
OB/GYN FILTER PACK
Version/Model Number
72102
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYD
Product Code Name
Apparatus, Exhaust, Surgical
Public Device Record Key
c65b3b77-007d-451f-934c-e90a0eba6f41
Public Version Date
August 10, 2018
Public Version Number
1
DI Record Publish Date
July 10, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |