Duns Number:025460908
Device Description: SYR 10ML L/L PC WHITE
Catalog Number
DYNJZ83559
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJZ83559
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
K061275,K061275
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
c7b4b35b-0ad1-4c5e-a202-0560c25c6bdc
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 20, 2022
Package DI Number
40888277804914
Quantity per Package
800
Contains DI Package
10888277804913
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 |