Duns Number:688817949
Device Description: Main device 1ea, LEG SLEEVE Large 2ea, Single Hose 1ea, Double Hose 1ea [One set box]
Catalog Number
-
Brand Name
SP-1000
Version/Model Number
SP10200-BL-2
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
K202395,K202395
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
1aea2f15-1f6c-4fee-9024-beaf6c86111a
Public Version Date
December 23, 2021
Public Version Number
1
DI Record Publish Date
December 15, 2021
Package DI Number
18809315671894
Quantity per Package
2
Contains DI Package
08809315671897
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 |