Duns Number:070556204
Device Description: Triangular Bandage (non-woven)
Catalog Number
1124-03680
Brand Name
Curaplex
Version/Model Number
1124-03680
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
ILI
Product Code Name
SLING, ARM
Public Device Record Key
16eacf60-fe96-464c-9747-222b1576e333
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 2017
Package DI Number
00817617023724
Quantity per Package
240
Contains DI Package
00817617023243
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 |