Duns Number:025460908
Device Description: CLIP HEMO EZ LOAD TIT 10/PK ME
Catalog Number
DYNJZ90088
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJZ90088
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
K841547,K841547
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
ebc851dd-a6b0-4a6a-8bc8-d5e114d63f24
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
November 07, 2016
Package DI Number
40888277805188
Quantity per Package
18
Contains DI Package
10888277805187
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 |