Duns Number:025460908
Device Description: CSTM TAVI DRAPE PACK
Catalog Number
DYNJCD0327
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJCD0327
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
-
Product Code
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
b9d7a5b3-8f3a-45b6-aeb1-b2640a7608ca
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
July 16, 2021
Package DI Number
40193489203883
Quantity per Package
10
Contains DI Package
10193489203882
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |