AccessGUDID - DEVICE: Perflex Thermofix (07290110501938)

GUDID

Device Identifier (DI) Information

Brand Name: Perflex Thermofix
Version or Model: White
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 455001
Company Name: PERFLEX LTD

Primary DI Number: 07290110501938
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532176000 *Terms of Use

Device Description: Thermoplastic pellets softens with a dip hot water to a pliable putty for immediate impression ,individual trays,bite registrations,night guards,extending walls,functional impressions,,jig in implants. Colour White 1kg net in jar

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
34799	Composite dental impression material	A thermoplastic material designed 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. It is composed of a mixture of natural resins, fillers, and lubricants. 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: 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c557a890-54a5-4018-ba4a-b39183907e26
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 25, 2017