Life Instruments - Bone Awl 7/16" - Life Instrument Corporation

Duns Number:948025002

Device Description: Bone Awl 7/16"

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More Product Details

Catalog Number

-

Brand Name

Life Instruments

Version/Model Number

749-8716-0

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

b516b6c9-5685-4353-8062-5e0d13a31437

Public Version Date

February 16, 2022

Public Version Number

1

DI Record Publish Date

February 08, 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