Catalog Number

-

Brand Name

FibriJet

Version/Model Number

SA-3305

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KYZ

Product Code Name

Syringe, Irrigating (Non Dental)

Public Device Record Key

e2633004-7534-4082-9c6a-ddb7d5633d25

Public Version Date

October 25, 2022

Public Version Number

2

DI Record Publish Date

June 08, 2022

Package DI Number

10815634021232

Quantity per Package

1

Contains DI Package

00815634021235

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack