Life Instruments - Cup Positioner - Life Instrument Corporation

Duns Number:948025002

Device Description: Cup Positioner

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More Product Details

Catalog Number

-

Brand Name

Life Instruments

Version/Model Number

792-1206-0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

5761b1f8-e47b-44cd-bb5d-933fc9fe82cf

Public Version Date

February 25, 2022

Public Version Number

1

DI Record Publish Date

February 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE INSTRUMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5454
2 A medical device with a moderate to high risk that requires special controls. 7