Duns Number:047047543
Device Description: SYRINGE 1.0ML 27GA 5/8IN 10BAG 500 BDD
Catalog Number
329412
Brand Name
BD PrecisionGlide Syringes, 1mL 27G x 5/8
Version/Model Number
329412
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K024112,K024112,K024112
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
ddd7aaef-e46b-49d1-8f5d-5a8cc82cef2c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 03, 2016
Package DI Number
50382903294126
Quantity per Package
5
Contains DI Package
30382903294122
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |