Life Instruments - 15" Endplate Rasp Str Dbl-Side 7" Handle - Life Instrument Corporation

Duns Number:948025002

Device Description: 15" Endplate Rasp Str Dbl-Side 7" Handle

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More Product Details

Catalog Number

-

Brand Name

Life Instruments

Version/Model Number

765-1522-0

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

HTR

Product Code Name

Rasp

Device Record Status

Public Device Record Key

ddf69a05-b138-4eb7-b4ab-ef6e5f93cc2a

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 04, 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