Duns Number:009260217
Device Description: Plastic disposable cotton roll holder 100 pack.Each clamp firmly holds two cotton rolls, s Plastic disposable cotton roll holder 100 pack.Each clamp firmly holds two cotton rolls, sizes 1,2 & 3.Provides a dry field without restricting access or visibility
Catalog Number
18600
Brand Name
Isolator Disposable Cotton Roll Holder 100 pack
Version/Model Number
18600
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFN
Product Code Name
Cotton, Roll
Public Device Record Key
09ddbc48-1fa9-4ee7-84e5-c72858e2d8a0
Public Version Date
July 17, 2019
Public Version Number
1
DI Record Publish Date
July 09, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 57 |