Catalog Number

-

Brand Name

Physician's Choice

Version/Model Number

DLH01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FTA

Product Code Name

Light, Surgical, Accessories

Public Device Record Key

64d567f1-f26b-4c90-8689-c72f731216ac

Public Version Date

August 18, 2021

Public Version Number

2

DI Record Publish Date

August 05, 2021

Package DI Number

G018DLH012

Quantity per Package

18

Contains DI Package

G018DLH010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case