AccessGUDID - DEVICE: OSUNG MND (08800075626370)

GUDID

Device Identifier (DI) Information

Brand Name: OSUNG MND
Version or Model: ARR1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OSUNG MND Co., Ltd.

Primary DI Number: 08800075626370
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688207479 *Terms of Use

Device Description: A non-powered component of a dental material heater designed to conduct heat from the heater’s heating element to a container holding a dental material/substance (e.g., composite resin, root canal cleaning solution, local anaesthetic agent). It is typically in the form of a metal block which incorporates holders of different shapes designed to accept specific devices/containers (e.g., vials, syringes, cartridges) for heating; it may include a cover. This is a reusable device.

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?
65224	Dental material heater plate	A non-powered component of a dental material heater designed to conduct heat from the heater’s heating element to a container holding a dental material/substance (e.g., composite resin, root canal cleaning solution, local anaesthetic agent). It is typically in the form of a metal block which incorporates holders of different shapes designed to accept specific devices/containers (e.g., vials, syringes, cartridges) for heating; it may include a cover. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 289da701-0544-420c-adfb-2d55054766ae
Public Version Date: March 04, 2024
Public Version Number: 1
DI Record Publish Date: February 23, 2024