Superhawk - Superhawk Drill Guide Circle - RESPONSIVE ORTHOPEDICS LLC

Duns Number:002745858

Device Description: Superhawk Drill Guide Circle

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More Product Details

Catalog Number

-

Brand Name

Superhawk

Version/Model Number

908012-0000

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

4b161351-f8ad-4507-816d-e6b37bb42cd0

Public Version Date

March 23, 2022

Public Version Number

1

DI Record Publish Date

March 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPONSIVE ORTHOPEDICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 106
2 A medical device with a moderate to high risk that requires special controls. 69