ZEUS-L - ZEUS®-L SLAP HAMMER KNOB - SPINAL ELEMENTS

Duns Number:004022104

Device Description: ZEUS®-L SLAP HAMMER KNOB

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More Product Details

Catalog Number

-

Brand Name

ZEUS-L

Version/Model Number

16-18-3

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

ba1d3ac6-8ee3-43be-8f11-9913403d71cc

Public Version Date

April 01, 2022

Public Version Number

3

DI Record Publish Date

May 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINAL ELEMENTS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1993
2 A medical device with a moderate to high risk that requires special controls. 3642
U Unclassified 15