Micro Plus - BIOMEDICAL LIFE SYSTEMS, INC.

Duns Number:116956807

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More Product Details

Catalog Number

KMICP

Brand Name

Micro Plus

Version/Model Number

Micro Plus

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K915210,K915210

Product Code Details

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Device Record Status

Public Device Record Key

a37e2bf1-3356-46ad-a33c-0268df6c93fc

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10857771003160

Quantity per Package

60

Contains DI Package

00857771003163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"BIOMEDICAL LIFE SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 80