Duns Number:102726734
Device Description: Snap Therapy System Snap 100mmHg Therapy Cartridge 60ml
Catalog Number
-
Brand Name
SNAP™
Version/Model Number
SNPA100US
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
K112341,K112341,K112341
Product Code
OKO
Product Code Name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Public Device Record Key
2ac9b4e7-42e5-4669-a875-98f071c97e59
Public Version Date
September 09, 2020
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20849554006045
Quantity per Package
10
Contains DI Package
00849554006041
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 |