AccessGUDID - DEVICE: Spiro® Colorinox® Sterile (J003A004B021025011)

GUDID

Device Identifier (DI) Information

Brand Name: Spiro® Colorinox® Sterile
Version or Model: A004B02102501
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A004B02102501
Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl

Primary DI Number: J003A004B021025011
Issuing Agency: HIBCC
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 480538495 *Terms of Use

Device Description: Endodontic Instrument, Barbed broach

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):	No
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?
63202	Endodontic broach, serrated, single-use	A hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKW	BROACH, ENDODONTIC

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: N/A

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3d59c24-648a-4457-ad48-e9236ae625bf
Public Version Date: June 06, 2025
Public Version Number: 2
DI Record Publish Date: September 30, 2022