Duns Number:025460908
Device Description: DBD-SYR W/NDLE,HYPODERM,LL,20GX1, 3ML
Catalog Number
SYR103205A
Brand Name
Medline
Version/Model Number
SYR103205A
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
3f82b0ca-e9dd-4f20-881c-2e0f5eb6b71b
Public Version Date
December 04, 2020
Public Version Number
1
DI Record Publish Date
November 26, 2020
Package DI Number
30193489005510
Quantity per Package
800
Contains DI Package
20193489005513
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 |