AccessGUDID - DEVICE: ScanBox pro (03770021392824)

GUDID

Device Identifier (DI) Information

Brand Name: ScanBox pro
Version or Model: 001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1012-001
Company Name: DENTAL MONITORING

Primary DI Number: 03770021392824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 269129881 *Terms of Use

Device Description: Cheeck Retractor for photo acquisition. ScanBox pro M-L Pack (without boxabox, plastic bag only) -The kit contains 4 elements: 2 Cheek Retractors: one Medium size (M) and one Large size (L). 1 Adapter 1 Phone support.

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:	Yes
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?
44828	Dental cheek retractor, professional, reusable	A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.	Active	false
63817	Dental cheek retractor, home-use	A hands-free, self-retaining frame intended to be used in the home by a patient to retract the lips/cheeks to facilitate viewing of the teeth (e.g., to allow photographs to be taken and sent to a healthcare professional). It is a synthetic polymer device designed to be placed in and around the lips/cheeks; it is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIG	Retractor, All Types

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: ad227415-2b54-48ab-bb99-15073c02d633
Public Version Date: February 17, 2025
Public Version Number: 2
DI Record Publish Date: September 16, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
03770021392855	36	03770021392824	In Commercial Distribution	Plastic bag
03760405340183	12	03770021392824	In Commercial Distribution
03760405340190	36	03760405340183	In Commercial Distribution