AccessGUDID - DEVICE: SR Ivolen (DIVO5303681)

GUDID

Device Identifier (DI) Information

Brand Name: SR Ivolen
Version or Model: 530368
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 530368
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO5303681
Issuing Agency: HIBCC
Commercial Distribution End Date: June 06, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: SR Ivolen Liquid 2500 ml

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?
58106	Dental impression tray material	A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBH	MATERIAL, IMPRESSION TRAY, RESIN

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: fcd60e77-713a-42c4-8ca7-0d01fa5705e0
Public Version Date: June 07, 2024
Public Version Number: 3
DI Record Publish Date: August 26, 2020