Duns Number:688817949
Device Description: CENTER BODY EXTENSION ZIPPER 2ea [One polybag]
Catalog Number
-
Brand Name
4 chamber extension zipper
Version/Model Number
4ECGF01
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150033,K202395,K203498,K150033,K202395,K203498,K150033,K202395,K203498,K150033,K202395,K203498,K150033,K202395,K203498
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
9bdf01a0-3be5-4063-872b-8eb9cde75f94
Public Version Date
December 27, 2021
Public Version Number
1
DI Record Publish Date
December 17, 2021
Package DI Number
18809802640662
Quantity per Package
5
Contains DI Package
08809802640665
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |