Catalog Number

LDIN628/S

Brand Name

AC DEVICE

Version/Model Number

LDIN628/S

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

Yes

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

K091207

Product Code

HWX

Product Code Name

Tap, Bone

Public Device Record Key

f8ce8a2b-de9e-4a57-b18f-e3ac7bd3be67

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-