AccessGUDID - DEVICE: Imprint™ 3 Quick Step Ultra-Regular Body (J001702011378020)

GUDID

Device Identifier (DI) Information

Brand Name: Imprint™ 3 Quick Step Ultra-Regular Body
Version or Model: 36955
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36955
Company Name: 3M Deutschland GmbH

Primary DI Number: J001702011378020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 315731711 *Terms of Use

Device Description: 3M™ ESPE™ Imprint™ 3 Quick Step Ultra Regular Body VPS Impression Material Refill, 36955

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
60855	Neurofilament light protein IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of neurofilament light protein in a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
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: 388dc0ad-fb0c-4c7b-be61-23d8db7e28fe
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016