Duns Number:961027315
Device Description: STERILE GYN PACK
Catalog Number
SMA3BGPEGC
Brand Name
CARDINAL HEALTH
Version/Model Number
SMA3BGPEGC
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)
Yes
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
OHD
Product Code Name
Gynecological laparoscopic kit
Public Device Record Key
4a80c5bc-56ec-4f41-9dbb-f0bccc82b0b2
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
50885425942655
Quantity per Package
3
Contains DI Package
10885425942657
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |