Duns Number:065762392
Device Description: Disposable 3cc Syringe LL, W/BioGuard Safety Needle 21G x 1 1/2", Each
Catalog Number
BIO-1052S
Brand Name
Syringe LL, W/BioCare Safety Needle
Version/Model Number
BIO-1052S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 31, 2030
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)
Yes
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
4799fdbf-afa0-41e4-a927-709c731e0301
Public Version Date
June 16, 2020
Public Version Number
3
DI Record Publish Date
September 29, 2019
Package DI Number
10858835007124
Quantity per Package
100
Contains DI Package
00858835007127
Package Discontinue Date
August 31, 2028
Package Status
In Commercial Distribution
Package Type
inner box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |