AccessGUDID - DEVICE: Amalgam Catches (00723896009291)

GUDID

Device Identifier (DI) Information

Brand Name: Amalgam Catches
Version or Model: 70-14420
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-14420
Company Name: PRACTICON, INC.

Primary DI Number: 00723896009291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Original Amalgam Catches "convert" a mouth mirror into a collection cup that helps prevent amalgam debris from falling down the throat. Plastic clip-on design reduces mirror fogging by shielding the glass from the patient's breath. Adds revenue by increasing valuable scrap recovery and recycling too

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):	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?
42333	Dental amalgam trap	A device designed to prevent waste amalgam from entering a mains drainage system.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EIF	Accessories, Retractor, Dental

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: 50f266ad-c3b4-4617-ac0b-751351d51365
Public Version Date: August 13, 2018
Public Version Number: 1
DI Record Publish Date: July 11, 2018