Quick-Start - Reverse Thread Quick-Start Screw 6mm x 25mm - INNOVATE ORTHOPAEDICS LIMITED

Duns Number:220348521

Device Description: Reverse Thread Quick-Start Screw 6mm x 25mm

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More Product Details

Catalog Number

10002R

Brand Name

Quick-Start

Version/Model Number

10002R

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

K212547

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

2eceed9b-8936-40a2-a906-3d2212747052

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVATE ORTHOPAEDICS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 30