Catalog Number

750107

Brand Name

Bulb Irrigation Tray

Version/Model Number

750107

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"

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

-

Product Code

KYZ

Product Code Name

SYRINGE, IRRIGATING (NON DENTAL)

Public Device Record Key

f664276d-3fcb-4d73-bbb9-1d71ac502e22

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Package DI Number

10801741051064

Quantity per Package

20

Contains DI Package

00801741051067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA