Duns Number:023904428
Device Description: Packing Strip Iodoform 5% 1/4"x5 yds
Catalog Number
-
Brand Name
McKesson
Version/Model Number
61-59145
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)
-
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
44844bd4-f7c7-4b03-a6fb-d524b6dd7be1
Public Version Date
February 11, 2019
Public Version Number
4
DI Record Publish Date
February 05, 2018
Package DI Number
40612479135992
Quantity per Package
12
Contains DI Package
10612479135984
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |