Catalog Number

0034049

Brand Name

ACE

Version/Model Number

0034049

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

-

Product Code

EBA

Product Code Name

LIGHT, SURGICAL HEADLIGHT

Public Device Record Key

cefa946b-914e-4ad0-9ea7-83b7ab7239c4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 21, 2015

Package DI Number

10614950000071

Quantity per Package

100

Contains DI Package

00614950000074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Poly Bag