BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

OSUNG MND

DI: 08800075627698 · Model: PLGWL1 · OSUNG MND Co., Ltd.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: OSUNG MND
Primary DI: 08800075627698
Version / Model: PLGWL1
Company Name: OSUNG MND Co., Ltd.
Labeler DUNS: 688207479
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-11-03
Public Version: 1
Public Version Date: 2025-11-11
Public Version Status: New
Public Device Record Key: a257f901-fa0b-448a-bc40-ba0dcd8dd281

Device Description

A small cup where mixed amalgam is put before being taken up by an amalgam carrier or an amalgam syringe. This is a reusable device.

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: Yes
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: Yes
Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKI	Carrier, Amalgam, Operative	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35867	Dental amalgam well	A small cup where mixed amalgam is put before being taken up by an amalgam carrier or an amalgam syringe. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800075627698	GS1