Duns Number:102726734
Device Description: Snap Therapy System Snap Plus 125mmHg Therapy Cartridge, 150ml
Catalog Number
-
Brand Name
SNAP™
Version/Model Number
SNPA125PLUS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OKO
Product Code Name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Public Device Record Key
5569f397-1fe1-43e7-8ca4-96d29e383c79
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20849554006021
Quantity per Package
10
Contains DI Package
00849554006027
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10 PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |