AccessGUDID - DEVICE: Healix (00810005666503)

GUDID

Device Identifier (DI) Information

Brand Name: Healix
Version or Model: CSRW-1000T-245
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.

Primary DI Number: 00810005666503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047486041 *Terms of Use

Device Description: 7.0 - 7.5 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16462	Surgical countersink, reusable	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWW	Countersink

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 06900f04-8e45-48c4-a016-983646e5c087
Public Version Date: January 20, 2020
Public Version Number: 2
DI Record Publish Date: September 30, 2019