AccessGUDID - DEVICE: SPEED Intra-Oral Reference Tool (07540295000451)

GUDID

Device Identifier (DI) Information

Brand Name: SPEED Intra-Oral Reference Tool
Version or Model: 07540295000451
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hespeler Orthodontics Limited

Primary DI Number: 07540295000451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203297635 *Terms of Use
Previous DI: 75402951100015

Device Description: No description.

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?
31799	Orthodontic appliance dimension gauge	A dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 2a33d034-927d-4b03-b37d-c45f21d35136
Public Version Date: August 19, 2024
Public Version Number: 1
DI Record Publish Date: August 09, 2024