NA - MODIFIED INSTRUMENT BALL TIP FEELER, LEFT, 11mm - DEPUY SPINE, LLC

Duns Number:107105876

Device Description: MODIFIED INSTRUMENT BALL TIP FEELER, LEFT, 11mm

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More Product Details

Catalog Number

698339874

Brand Name

NA

Version/Model Number

698339874

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

GDG

Product Code Name

HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

a000e06a-1d52-46e6-aa6e-79296935170d

Public Version Date

February 10, 2022

Public Version Number

1

DI Record Publish Date

February 02, 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