Catalog Number

LDIN627/S

Brand Name

AC DEVICE

Version/Model Number

LDI627/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

HTW

Product Code Name

Bit, Drill

Public Device Record Key

8b37883b-56c6-4f19-8d86-f488b14d5645

Public Version Date

July 23, 2020

Public Version Number

6

DI Record Publish Date

February 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-