AccessGUDID - DEVICE: Health-Tec/DHP Amalgam Carriers (D773700100030)

GUDID

Device Identifier (DI) Information

Brand Name: Health-Tec/DHP Amalgam Carriers
Version or Model: 700-10003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700-10003
Company Name: Dental Health Products Inc

Primary DI Number: D773700100030
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 Amalgam Carriers Mini/Regular Double End Stainless Steel Tips

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?
35696	Dental amalgam carrier	A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKI	Carrier, Amalgam, Operative

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: 3b8460ef-0f6f-4726-9912-c3159a08610f
Public Version Date: November 17, 2022
Public Version Number: 1
DI Record Publish Date: November 09, 2022