Catalog Number

-

Brand Name

iDrive

Version/Model Number

INTBIC1

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

K102325

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

7ba18492-c15e-46ff-b9d2-2e11c36e4539

Public Version Date

September 23, 2022

Public Version Number

5

DI Record Publish Date

September 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-