AccessGUDID - DEVICE: Affinity™ Crystal Cartridge (00359883001476)

GUDID

Device Identifier (DI) Information

Brand Name: Affinity™ Crystal Cartridge
Version or Model: 011400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 011400
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: 00359883001476
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: Clear Matrix Impression Material

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:	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 [?]
K073005	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
Storage Environment Temperature: between 65 and 75 Degrees Fahrenheit
Special Storage Condition, Specify: Ensure Adequate Ventilation
Storage Environment Temperature: between 18 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 50 Milliliter

Device Record Status

Public Device Record Key: f63c8dd7-59f8-4520-a0c2-113bb217a152
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025