Catalog Number

-

Brand Name

GIALLOY CB BLANK

Version/Model Number

5895121 Gestuft SRL 12 mm 10 St.

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJH

Product Code Name

Alloy, Metal, Base

Public Device Record Key

73d062a1-e841-4bc4-8ba6-83ebac2a0ece

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-