AccessGUDID - DEVICE: T-Scan Core Novus (B970DC10)

GUDID

Device Identifier (DI) Information

Brand Name: T-Scan Core Novus
Version or Model: T-Scan Novus Core System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DC1
Company Name: Tekscan, Inc.

Primary DI Number: B970DC10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 178180246 *Terms of Use

Device Description: T-Scan Core Software, 1 Novus Handpiece (USB Connection), 1 Novus Handpiece Holder, 20 Large & 20 Small Sensors, 2 Large & 2 Small Sensor Supports, 90 Day Free Customer Support, One Year Parts & Labor Warranty, Interactive Help File, Electronic Operations Manual.

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?
16181	Dental articulation paper	A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFH	Paper, Articulation

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 250b3351-bf35-4945-b6fd-2ba002938fcc
Public Version Date: November 11, 2020
Public Version Number: 1
DI Record Publish Date: November 03, 2020