AccessGUDID - DEVICE: DigiFuse® Cannulated Intramedullary Fusion System (10381780244844)

GUDID

Device Identifier (DI) Information

Brand Name: DigiFuse® Cannulated Intramedullary Fusion System
Version or Model: DW-2590
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DW-2590
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780244844
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: Integra® DigiFuse® The smooth guide wire is used as a guide for placement or insertion of a device.

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?
46165	Orthopaedic guidewire, reusable	A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXI	PASSER, WIRE, ORTHOPEDIC

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
Device Size Text, specify: 2.756 in L x .031 in dia

Device Record Status

Public Device Record Key: aa9dfb6a-bd13-41ae-8a4c-f6cabb2369e5
Public Version Date: September 11, 2024
Public Version Number: 6
DI Record Publish Date: September 05, 2017