Duns Number:025460908
Device Description: ENDO KIT
Catalog Number
DYKE1442A
Brand Name
Medline Industries, Inc.
Version/Model Number
DYKE1442A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 08, 2022
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
NWU
Product Code Name
Endoscope introducer kit
Public Device Record Key
4c9386f5-32e5-47bb-a1d2-a71a1548f7b9
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
August 28, 2018
Package DI Number
40889942554530
Quantity per Package
18
Contains DI Package
10889942554539
Package Discontinue Date
March 08, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| 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 |