Duns Number:543007373
Device Description: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be u A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
Catalog Number
HWSY1mlLL2525
Brand Name
Syringe with safety needle
Version/Model Number
LL - 1ml 25G X 1"
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
K190183,K190183,K190183
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
c3dd0dbf-f5fa-4f40-9e95-8276ff8e29e7
Public Version Date
April 07, 2021
Public Version Number
1
DI Record Publish Date
March 30, 2021
Package DI Number
16958697602704
Quantity per Package
100
Contains DI Package
06958697602707
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-