Duns Number:070556204
Device Description: Curaplex Rolled Gauze, 3 ply, 3” x 4 yd, Non-Sterile
Catalog Number
1121-36335
Brand Name
Curaplex
Version/Model Number
1121-36335
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
7b5f60e0-fc37-4a06-a849-f40e96316bbe
Public Version Date
August 23, 2018
Public Version Number
3
DI Record Publish Date
March 15, 2017
Package DI Number
00817617022819
Quantity per Package
8
Contains DI Package
00817617022796
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 |