Catalog Number

SSI004765

Brand Name

Bigliani/Flatow

Version/Model Number

SSI004765

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

-

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

HXC

Product Code Name

Wrench

Public Device Record Key

f8986354-5bd4-42cf-b0cc-1352b3ce0e2a

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-