CoLink® 2 - CoLink® VAL Screw, Ø3.0 X 32mm - IN2BONES USA, LLC

Duns Number:079700711

Device Description: CoLink® VAL Screw, Ø3.0 X 32mm

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More Product Details

Catalog Number

-

Brand Name

CoLink® 2

Version/Model Number

P43 ST232

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K201149

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

ea82ec7b-36cb-4470-bea5-2269a13f3e0b

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IN2BONES USA, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113
2 A medical device with a moderate to high risk that requires special controls. 1255