AccessGUDID - DEVICE: NA (M595D631ADAPT0)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: D631ADAPT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D631ADAPT
Company Name: PARKELL, INC.

Primary DI Number: M595D631ADAPT0
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 009900424 *Terms of Use

Device Description: New - Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New FDA Lead Wire Regulation)

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?
13187	Dental pulp analysis system	An assembly of devices designed to evaluate the pulpal vitality of teeth by electrically stimulating the nerve tissue of the pulp. The electric current needed to obtain a patient response to the stimulus is a measure of the condition of the dental pulp. The system typically includes a high frequency electronic oscillator, cables, and electrodes to apply the electrical signal; a display may be included. The system is used for determination of pulp necrosis, pulpitis, and involvement of teeth that approximate lesions (i.e., teeth that are next to diseased tissue).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAT	Tester, Pulp

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: c7763d5c-0743-4ad5-a4fa-eca8c4819735
Public Version Date: April 01, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016