Duns Number:080935429
Device Description: Hypertonic Sodium Chloride Packing Strip
Catalog Number
3335
Brand Name
Curity
Version/Model Number
3335
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
KMF
Product Code Name
Bandage, liquid
Public Device Record Key
886da74d-3171-4286-8623-bb4e02630855
Public Version Date
December 06, 2021
Public Version Number
4
DI Record Publish Date
June 23, 2018
Package DI Number
20884527016652
Quantity per Package
12
Contains DI Package
10884527016655
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 | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |