NavLock - HANDLE 9733734 RATCHETING QC SM STRGHT - MEDTRONIC NAVIGATION, INC.

Duns Number:835233107

Device Description: HANDLE 9733734 RATCHETING QC SM STRGHT

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More Product Details

Catalog Number

-

Brand Name

NavLock

Version/Model Number

9733734

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)

-

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

38adff56-6c48-459d-918d-858d4ab4c0ed

Public Version Date

October 19, 2018

Public Version Number

2

DI Record Publish Date

September 06, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC NAVIGATION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 1961
3 A medical device with high risk that requires premarket approval 1