AccessGUDID - DEVICE: Health-Tec/DHP Endo-Aids (D773330100011)

GUDID

Device Identifier (DI) Information

Brand Name: Health-Tec/DHP Endo-Aids
Version or Model: 330-10001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 330-10001
Company Name: Dental Health Products Inc

Primary DI Number: D773330100011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623191194 *Terms of Use

Device Description: Health-tec/DHP Endo-Aid Organizer Kit (1 Ring - 25 each Lavender and Teal foam refills)

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:	Yes
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?
64861	Endodontic cold test foam wedge	A section of soft, spongy, compressible material intended to be used to perform a dental cold sensitivity test for detection of a dental fracture hidden beneath tooth enamel or a cusp, and/or to assess dental pulp health. It is designed to be submitted to very low temperatures, typically by being sprayed or injected with a coolant fluid, and then applied to a patient’s tooth surface to elicit a painful response. Tweezers-like tips intended to be mounted on a hand-held instrument while holding the foam wedges may be included with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAB	Gauze / Sponge,Nonresorbable For External Use

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: 6bbc24ec-6b7d-411c-924a-2615d8833820
Public Version Date: October 24, 2022
Public Version Number: 1
DI Record Publish Date: October 14, 2022