FDA UDI In Commercial Distribution 🇺🇸 United States

DEROYAL

DI: 16939029815696 · Model: 659956 · Modern Medical Equipment MFG. Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500

Basic Information

Brand Name
DEROYAL
Primary DI
16939029815696
Version / Model
659956
Company Name
Modern Medical Equipment MFG. Ltd.
Labeler DUNS
527812392
Distribution Status
In Commercial Distribution
Device Count in Pkg
500
Record Status
Published
Publish Date
2017-12-12
Public Version
3
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
6693e5d7-0b77-4c51-8e01-b7259a2edf0c

Device Description

Open-surgery electrosurgical electrode, monopolar, single-use

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
61874 Open-surgery electrosurgical electrode, monopolar, single-use

Identifiers

Type ID
Package 26939029815693
Primary 16939029815696
Unit of Use 06939029815699