Duns Number:961027315
Device Description: IODOFORM PACKING STRIP 1/4INX5YD ST
Catalog Number
C-PG145I
Brand Name
CARDINAL HEALTH
Version/Model Number
C-PG145I
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FER
Product Code Name
Anoscope and accessories
Public Device Record Key
be80f586-7562-437e-9f04-0f2d84a2fb1b
Public Version Date
June 06, 2019
Public Version Number
1
DI Record Publish Date
May 29, 2019
Package DI Number
50885380052208
Quantity per Package
12
Contains DI Package
10885380052200
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 |