Duns Number:103169095
Device Description: 9" X 9" NON-STERILE BULK PACKED, POLYESTER LASER SEALED EDGE 140 GRAM WIPERS - 100 wipers 9" X 9" NON-STERILE BULK PACKED, POLYESTER LASER SEALED EDGE 140 GRAM WIPERS - 100 wipers PER BAG
Catalog Number
-
Brand Name
NON-STERILE WIPERS
Version/Model Number
PW0909100
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
d9d9ca67-1eba-4373-ad78-b0c18a2f8d9a
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
10843356102489
Quantity per Package
6
Contains DI Package
00843356102482
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 |