AccessGUDID - DEVICE: Sonoma Orthopedic Products, Inc (00816988010326)

GUDID

Device Identifier (DI) Information

Brand Name: Sonoma Orthopedic Products, Inc
Version or Model: IN0066
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IN0066
Company Name: ARTHREX, INC.

Primary DI Number: 00816988010326
Issuing Agency: GS1
Commercial Distribution End Date: July 07, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: 3.5mm Syndesmotic Drill, Non-sterile

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:	Yes
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?
36585	Patient monitoring system module, printing	A small unit dedicated to providing a print-out of patient related data, e.g., an electrocardiogram (ECG), blood pressure, haemoglobin oxygen saturation (SpO2). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer providing the information requested for the print-outs from this module.	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: f16d116d-ceb1-45a6-bc88-921ceba2281a
Public Version Date: July 28, 2025
Public Version Number: 5
DI Record Publish Date: July 07, 2017