Duns Number:025460908
Device Description: SYR W/NDLE,HYPODERM,LL,21GX1.5", 5ML
Catalog Number
SYR105217
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
SYR105217
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
07e6e4ce-c3ae-4173-941e-90bc9dba40ac
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
Package DI Number
30080196449594
Quantity per Package
100
Contains DI Package
10080196449590
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |