Catalog Number

128770

Brand Name

GEM IntraOp Doppler, Hand-Held Dopplers

Version/Model Number

128770

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

K082870,K082870

Product Code

DPW

Product Code Name

FLOWMETER, BLOOD, CARDIOVASCULAR

Public Device Record Key

f6b14a9a-38f3-46a1-a8fb-a5aa7920f37f

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-