Catalog Number

65607758

Brand Name

Kulzer

Version/Model Number

65607758

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"

-

For Single-Use

-

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

EHY

Product Code Name

TRAY, IMPRESSION, PREFORMED

Public Device Record Key

20f41960-7869-47aa-8040-b9d8f632b0b8

Public Version Date

April 13, 2021

Public Version Number

1

DI Record Publish Date

April 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-