FDA UDI In Commercial Distribution 🇺🇸 United States

OSUNG MND

DI: 08800075602893 · Model: DMCS4 · OSUNG MND Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
OSUNG MND
Primary DI
08800075602893
Version / Model
DMCS4
Company Name
OSUNG MND Co., Ltd.
Labeler DUNS
688207479
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-02-19
Public Version
1
Public Version Date
2024-02-27
Public Version Status
New
Public Device Record Key
fc4259f0-dced-47c0-84fa-2b92a03ef261

Device Description

A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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
EAX Mirror, Mouth

GMDN Terms

Code Name
31776 Dental mirror, reusable

Identifiers

Type ID
Primary 08800075602893