AccessGUDID - DEVICE: OptraGate Small Refill (DIVO590851WW1)

GUDID

Device Identifier (DI) Information

Brand Name: OptraGate Small Refill
Version or Model: 590851WW
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 590851WW
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO590851WW1
Issuing Agency: HIBCC
Commercial Distribution End Date: April 09, 2021
Device Count: 80
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: OptraGate Small Refill

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?
45004	Rubber dam, non-latex	A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. 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: 05143a2e-69cf-46cc-8e3f-f1e40485f828
Public Version Date: April 16, 2021
Public Version Number: 1
DI Record Publish Date: April 08, 2021