Duns Number:103169095
Device Description: Clear Path disposable wipers with heat-sealed edges, constructed of woven, lint-free, part Clear Path disposable wipers with heat-sealed edges, constructed of woven, lint-free, particulate-free microfiber - 25 Wipers per Bag
Catalog Number
-
Brand Name
Clear Path disposable wipers
Version/Model Number
FS4193
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
FRL
Product Code Name
Fiber, Medical, Absorbent
Public Device Record Key
b2fd00fd-f048-4658-a465-8ab7de0c4b4f
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
10843356101925
Quantity per Package
4
Contains DI Package
00843356101928
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 146 |