Duns Number:115690369
Device Description: The StaClear Model SC250LS Syringe is a single-use piston syringe consisting of a graduate The StaClear Model SC250LS Syringe is a single-use piston syringe consisting of a graduated barrel, plunger, and plunger stopper. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Syringe is suitable for ophthalmic use.
Catalog Number
-
Brand Name
StaClear
Version/Model Number
SC250LS
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
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
d2202f7d-9243-4a4c-bd18-39dc170d4a2a
Public Version Date
August 16, 2022
Public Version Number
1
DI Record Publish Date
August 08, 2022
Package DI Number
B994SC250LS2
Quantity per Package
30
Contains DI Package
B994SC250LS0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pouch