Life Instruments - Bone Tamp 11" 11mm x 3mm - Life Instrument Corporation

Duns Number:948025002

Device Description: Bone Tamp 11" 11mm x 3mm

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More Product Details

Catalog Number

-

Brand Name

Life Instruments

Version/Model Number

863-1111-0

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

HXG

Product Code Name

Tamp

Device Record Status

Public Device Record Key

816b2ec6-54c3-499f-9247-b0c9b66b4e5e

Public Version Date

August 26, 2021

Public Version Number

1

DI Record Publish Date

August 18, 2021

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