Catalog Number

750101

Brand Name

Bulb Irrigation Tray

Version/Model Number

750101

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

aa3203a9-053c-405a-8e44-396901287c80

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Package DI Number

10801741051057

Quantity per Package

20

Contains DI Package

00801741051050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA