AccessGUDID - DEVICE: Inion Hexalon instrument (M224INS920610)

GUDID

Device Identifier (DI) Information

Brand Name: Inion Hexalon instrument
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: INS-9206
Company Name: Inion Oy

Primary DI Number: M224INS920610
Issuing Agency: HIBCC
Commercial Distribution End Date: October 10, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 367994657 *Terms of Use

Device Description: Starter, 8/9 mm

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?
32859	Orthopaedic bone screw starter/notcher	A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDR	Staple, fixation, bone
HWC	Screw, fixation, bone
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071464	000

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: 0b404234-2d59-4de8-a6a5-9afc64436cb0
Public Version Date: October 11, 2018
Public Version Number: 5
DI Record Publish Date: August 31, 2016