General Instrument - Extractor, Modified - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: Extractor, Modified

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More Product Details

Catalog Number

01-1000-903

Brand Name

General Instrument

Version/Model Number

01-1000-903

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

-

Product Code Details

Product Code

HWB

Product Code Name

EXTRACTOR

Device Record Status

Public Device Record Key

57f657b3-a09c-465a-915b-cdb71dfde16a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOPEDIATRICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1662
2 A medical device with a moderate to high risk that requires special controls. 7273