AccessGUDID - DEVICE: TorqLoc Instrument (E302OPII80109)

GUDID

Device Identifier (DI) Information

Brand Name: TorqLoc Instrument
Version or Model: OP-II-8010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OP-II-8010
Company Name: Bioretec Oy

Primary DI Number: E302OPII80109
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 368715301 *Terms of Use

Device Description: TorqLoc Notcher for 7/8/9/10 mm interference screw

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
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: ce40075b-40e5-4f3b-827d-fb8557bf804c
Public Version Date: April 13, 2023
Public Version Number: 3
DI Record Publish Date: February 15, 2017