AccessGUDID - DEVICE: OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS (08800000995724)

GUDID

Device Identifier (DI) Information

Brand Name: OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
Version or Model: K3-Chair only
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osstem Implant Co.,Ltd.

Primary DI Number: 08800000995724
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695235881 *Terms of Use

Device Description: A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor and occasionally the operating light. The patient examination/treatment chair is often connected to this unit.

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?
34991	Dental delivery system	A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRU	Chair, Dental, Without Operative Unit

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: 83e978c4-00e9-4945-91b1-3c76b2e55954
Public Version Date: November 07, 2022
Public Version Number: 1
DI Record Publish Date: October 28, 2022