AccessGUDID - DEVICE: OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS (08800000995830)

GUDID

Device Identifier (DI) Information

Brand Name: OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
Version or Model: HYMIX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osstem Implant Co.,Ltd.

Primary DI Number: 08800000995830
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695235881 *Terms of Use

Device Description: No description.

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?
10082	Dental amalgam mixer	A mains electricity (AC-powered) device used to shake a homogenous mixture of fine dental alloy particles [e.g., tin (Sn), silver (Ag), zinc (Zn), or copper (Cu)] with mercury (Hg) to obtain a dental amalgam, typically right before application. The amalgam is usually prepared in an appropriate capsule that may or may not be an integral part of the device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFD	Amalgamator, Dental, Ac-Powered

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: f8b1f94b-9182-4b53-ba84-e5a8a68a447a
Public Version Date: November 08, 2022
Public Version Number: 1
DI Record Publish Date: October 31, 2022