Healix - 2.0 Headless Countersink. The HEALIX - NVISION BIOMEDICAL TECHNOLOGIES, INC.

Duns Number:047486041

Device Description: 2.0 Headless Countersink. The HEALIX Compression Screw (HCS) System is indicated for Bon 2.0 Headless Countersink. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

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More Product Details

Catalog Number

-

Brand Name

Healix

Version/Model Number

CSRW-1000T-226

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

HWW

Product Code Name

Countersink

Device Record Status

Public Device Record Key

2e927991-aea1-4942-a146-3de39164d751

Public Version Date

August 19, 2020

Public Version Number

1

DI Record Publish Date

August 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NVISION BIOMEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 461
2 A medical device with a moderate to high risk that requires special controls. 1046