AccessGUDID - DEVICE: Prosthetic Silicone Materials (05060483012452)

GUDID

Device Identifier (DI) Information

Brand Name: Prosthetic Silicone Materials
Version or Model: CoForm Soft Impression Material – 40g
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M517
Company Name: TECHNOVENT LIMITED

Primary DI Number: 05060483012452
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 225835156 *Terms of Use

Device Description: Cartridge based silicone materials for taking external impressions to aid the construction of prostheses.

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):	No
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
GBI	Material, External Aesthetic Restoration, Used With Adhesive

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Special Storage Condition, Specify: The Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd7c1ba7-20fa-4596-8eed-ae83759005b2
Public Version Date: July 30, 2024
Public Version Number: 1
DI Record Publish Date: July 22, 2024