FDA UDI In Commercial Distribution 🇺🇸 United States

OSUNG MND

DI: 08800075603418 · Model: RDC210 · OSUNG MND Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
OSUNG MND
Primary DI
08800075603418
Version / Model
RDC210
Company Name
OSUNG MND Co., Ltd.
Labeler DUNS
688207479
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-02-23
Public Version
1
Public Version Date
2024-03-04
Public Version Status
New
Public Device Record Key
680c5613-dcde-4416-be4f-af27b21db17c

Device Description

A dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. 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
EEF Clamp, Rubber Dam

GMDN Terms

Code Name
15712 Rubber dam clamp

Identifiers

Type ID
Primary 08800075603418