Duns Number:070556204
Device Description: Curaplex Sterile, Sponge, non Woven 4 Ply, 4" x 4" 2/PK 50PK/BX
Catalog Number
1212-12106
Brand Name
Curaplex
Version/Model Number
1212-12106
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
2e2257f2-041f-457f-ab76-9e9c5e6f694d
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
December 15, 2018
Package DI Number
00812277030389
Quantity per Package
24
Contains DI Package
00812277030297
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |