NA - MODIFIED INSTRUMENT LEVER LOCK CLAMP - DEPUY SPINE, LLC

Duns Number:107105876

Device Description: MODIFIED INSTRUMENT LEVER LOCK CLAMP

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More Product Details

Catalog Number

698344731

Brand Name

NA

Version/Model Number

698344731

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

40ec53eb-7f4b-4d09-8a48-2aa45b92fa00

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5839
2 A medical device with a moderate to high risk that requires special controls. 2784
U Unclassified 20