FDA UDI In Commercial Distribution 🇺🇸 United States

OSUNG MND

DI: 08800075621795 · Model: BEPD2 · OSUNG MND Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
OSUNG MND
Primary DI
08800075621795
Version / Model
BEPD2
Company Name
OSUNG MND Co., Ltd.
Labeler DUNS
688207479
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-03-06
Public Version
1
Public Version Date
2024-03-14
Public Version Status
New
Public Device Record Key
ad7e9e4b-82b6-46de-ae52-a6b5d3e4f166

Device Description

A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. 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
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
45147 Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Identifiers

Type ID
Primary 08800075621795