Duns Number:200564891
Device Description: 2 in X 5 yards gauze packing iodoform strip in bottles with dispenser insert.
Catalog Number
DUP59445
Brand Name
Pak-its®
Version/Model Number
59445
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
FER
Product Code Name
Anoscope and accessories
Public Device Record Key
fcc33e82-ca43-4d41-9203-338d26a20479
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
October 23, 2018
Package DI Number
30381780491945
Quantity per Package
12
Contains DI Package
10381780491941
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 | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |