AccessGUDID - DEVICE: OptraGate 2 (DVIV757912WW1)

GUDID

Device Identifier (DI) Information

Brand Name: OptraGate 2
Version or Model: 757912WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 757912WW
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV757912WW1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: OptraGate 2 Regular Refill / 80

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?
63315	Dental cheek retractor, professional, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIF	ACCESSORIES, RETRACTOR, DENTAL

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: 6221c94d-3835-4e97-86cf-dbb9d8efb1c8
Public Version Date: December 03, 2024
Public Version Number: 2
DI Record Publish Date: November 19, 2024