Duns Number:115690369
Device Description: The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated bar The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic use.
Catalog Number
SC250
Brand Name
StaClear
Version/Model Number
SC250
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K200242,K200242,K200242,K200242,K200242
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
2b3b5703-559a-4ff2-bc02-70f52081f335
Public Version Date
August 03, 2022
Public Version Number
2
DI Record Publish Date
December 11, 2020
Package DI Number
B994SC2501
Quantity per Package
10
Contains DI Package
B994SC2500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bag