Duns Number:025460908
Device Description: ENDO KIT
Catalog Number
DYKE1060G
Brand Name
Medline Industries, Inc.
Version/Model Number
DYKE1060G
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"
Yes
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
OEZ
Product Code Name
Cardiovascular procedure kit
Public Device Record Key
ba2c2727-0760-4e13-9bb3-8bec57a6ef9c
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
January 27, 2019
Package DI Number
40889942967873
Quantity per Package
9
Contains DI Package
10889942967872
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 |