Duns Number:070556204
Device Description: Curaplex Fluff Bandage Roll, 2.25” x 3 yds, Sterile
Catalog Number
1121-36225
Brand Name
Curaplex
Version/Model Number
1121-36225
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
NAB
Product Code Name
Gauze/sponge,nonresorbable for external use
Public Device Record Key
458277d8-d651-4b7f-ba17-f10995f8576e
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
March 15, 2017
Package DI Number
00817617022802
Quantity per Package
96
Contains DI Package
00817617022789
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |