Formula - XL, Hip 8-Flute Barrel Bur. Arthroscopic Shaver - STRYKER CORPORATION

Duns Number:187502109

Device Description: XL, Hip 8-Flute Barrel Bur. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, 037 XL, Hip 8-Flute Barrel Bur. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, 0375-704-500, 0375-708-500. Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight

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More Product Details

Catalog Number

0385-951-008

Brand Name

Formula

Version/Model Number

0385951008

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

Yes

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

GFF

Product Code Name

BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

652607bf-ef06-4a7e-8dc3-a8b8b3765e6e

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

October 22, 2018

Additional Identifiers

Package DI Number

37613327055185

Quantity per Package

5

Contains DI Package

07613327055184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60