AccessGUDID - DEVICE: FLEXITIME XTREME HEAVY TRAY REF. 6X50 ML (J014660196850)

GUDID

Device Identifier (DI) Information

Brand Name: FLEXITIME XTREME HEAVY TRAY REF. 6X50 ML
Version or Model: 66019685
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66019685
Company Name: Kulzer GmbH

Primary DI Number: J014660196850
Issuing Agency: HIBCC
Commercial Distribution End Date: August 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315666321 *Terms of Use

Device Description: Material, Impression

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):	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?
35864	Polyether dental impression material	An elastomeric, polyether-based material capable of reacting to form a rubber-like substance used 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 [?]
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: 382426f8-6597-4724-b055-7ffdd7f4fcb7
Public Version Date: October 30, 2024
Public Version Number: 5
DI Record Publish Date: September 15, 2016