PEMF - PHYSIO-STIM - 5302CM, SHIP ASSY., BONE GROWTH STIMULATOR, - ORTHOFIX INC.

Duns Number:927083808

Device Description: 5302CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM

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More Product Details

Catalog Number

5302CM

Brand Name

PEMF - PHYSIO-STIM

Version/Model Number

655302-0005

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"

Yes

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

P850007

Product Code Details

Product Code

LOF

Product Code Name

Stimulator, bone growth, non-invasive

Device Record Status

Public Device Record Key

f519f68c-b244-4a67-8385-5363d4aa2f52

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOFIX INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2497
2 A medical device with a moderate to high risk that requires special controls. 5891
3 A medical device with high risk that requires premarket approval 104