Duns Number:025460908
Device Description: DBD-SYR W/NDLE,HYPODERM,TB,28GX 1/2, 1ML
Catalog Number
SYR101282A
Brand Name
Medline
Version/Model Number
SYR101282A
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
ac49fce3-d2d3-4f57-b3b4-1b88622bf35b
Public Version Date
December 21, 2020
Public Version Number
1
DI Record Publish Date
December 11, 2020
Package DI Number
30193489005503
Quantity per Package
800
Contains DI Package
20193489005506
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 |