AccessGUDID - DEVICE: PROTESIL INDURENT GEL 60 ML (08033712561158)

GUDID

Device Identifier (DI) Information

Brand Name: PROTESIL INDURENT GEL 60 ML
Version or Model: 056021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 056021
Company Name: VANNINI DENTAL INDUSTRY SRL

Primary DI Number: 08033712561158
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436650394 *Terms of Use

Device Description: Catalyst for C-silicones

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELW	MATERIAL, IMPRESSION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K935892	000

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
Special Storage Condition, Specify: Handling Environment Temperature
Storage Environment Temperature: between 4 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 60 Milliliter

Device Record Status

Public Device Record Key: 684fa3e0-407f-4552-973f-c84e55696d91
Public Version Date: July 01, 2021
Public Version Number: 2
DI Record Publish Date: September 06, 2019