Duns Number:025460908
Device Description: GAUZE,SPONGE,POST-OP,4X4,STERILE
Catalog Number
CUR21442
Brand Name
Curad
Version/Model Number
CUR21442
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
49b8be06-aa6f-46a2-81c7-677d175414fd
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
March 03, 2021
Package DI Number
40080196305040
Quantity per Package
24
Contains DI Package
30080196305043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
RETAIL OUTER PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |