Duns Number:091999771
Device Description: Cast and wound protector
Catalog Number
-
Brand Name
Seal-Tight
Version/Model Number
20317
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
-
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
IPM
Product Code Name
Cover, Limb
Public Device Record Key
d37ca1e2-61f7-42e0-ab08-f5e62173f85e
Public Version Date
September 01, 2020
Public Version Number
2
DI Record Publish Date
August 11, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 395 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |