AccessGUDID - DEVICE: Sonoma Orthopedic Products, Inc (00816988011835)

GUDID

Device Identifier (DI) Information

Brand Name: Sonoma Orthopedic Products, Inc
Version or Model: IN6040
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IN6040
Company Name: ARTHREX, INC.

Primary DI Number: 00816988011835
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: Compression Driver

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?
48025	Orthopaedic bone-fragment manipulator, reusable	A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. 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: 9aed9b39-7749-4c27-b40d-e114233606c1
Public Version Date: July 28, 2025
Public Version Number: 4
DI Record Publish Date: August 19, 2015