Duns Number:688817949
Device Description: Main device 1ea, CALF SLEEVE Medium [3CAGF10] 2ea, Tubing(81cm) 2ea [One set box]
Catalog Number
-
Brand Name
DVT-PRO
Version/Model Number
DVTP200-SC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203353,K203353
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
06efc460-f09b-4d7a-9c15-6b2825e04481
Public Version Date
June 30, 2021
Public Version Number
1
DI Record Publish Date
June 22, 2021
Package DI Number
18809315679845
Quantity per Package
8
Contains DI Package
08809315679848
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 |