AccessGUDID - DEVICE: PRESTIGE REGULAR 2 X 50 ML (08033712562193)

GUDID

Device Identifier (DI) Information

Brand Name: PRESTIGE REGULAR 2 X 50 ML
Version or Model: 055205
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 055205
Company Name: VANNINI DENTAL INDUSTRY SRL

Primary DI Number: 08033712562193
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436650394 *Terms of Use

Device Description: Vinylpolisiloxane for impressions

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 [?]
K972027	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: 100 Milliliter

Device Record Status

Public Device Record Key: 6cc5d8a3-6207-4b80-818b-cd02c1654521
Public Version Date: October 11, 2021
Public Version Number: 3
DI Record Publish Date: September 06, 2019