Catalog Number

INTBIG

Brand Name

iDrive

Version/Model Number

INTBIG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 02, 2019

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

K102325

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

48f7c0c7-48ce-4470-ae09-016d4b2b85a7

Public Version Date

August 14, 2020

Public Version Number

6

DI Record Publish Date

September 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-