Duns Number:102726734
Device Description: Snap Therapy System Snap Bridge Dressing Kit14 cm X 11 cm Bridge Dressing Kit8 cm X 8 cm F Snap Therapy System Snap Bridge Dressing Kit14 cm X 11 cm Bridge Dressing Kit8 cm X 8 cm Foam
Catalog Number
-
Brand Name
SNAP™
Version/Model Number
BKTF14X11
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
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
K132080,K132080,K132080
Product Code
OKO
Product Code Name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Public Device Record Key
80e7e225-b335-4091-b1de-18a57a8bd7e6
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20849554005406
Quantity per Package
10
Contains DI Package
00849554005402
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 |