Duns Number:809784593
Device Description: Surepress® Absorbent Padding - 4" X 3.2 Yds.
Catalog Number
650948
Brand Name
SUREPRESS
Version/Model Number
650948
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)
Yes
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
75d95aa7-6947-48d6-9075-e4f717d5d1c0
Public Version Date
October 28, 2022
Public Version Number
3
DI Record Publish Date
September 05, 2022
Package DI Number
10768455108968
Quantity per Package
24
Contains DI Package
00768455108961
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 116 |
U | Unclassified | 8 |