FDA UDI In Commercial Distribution 🇺🇸 United States

Bovie

DI: 06939029816313 · Model: 21-007-001 · Modern Medical Equipment MFG. Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Bovie
Primary DI
06939029816313
Version / Model
21-007-001
Company Name
Modern Medical Equipment MFG. Ltd.
Labeler DUNS
527812392
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-11-29
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
21b1f5c1-facb-4e46-b1eb-9c45fee70010

Device Description

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Device Characteristics

Single Use
No
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
Moist Heat or Steam Sterilization

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
47848 Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Identifiers

Type ID
Package 26939029816317
Package 16939029816310
Primary 06939029816313