FDA UDI In Commercial Distribution 🇺🇸 United States

OSSEODUO Foot Pedal

DI: 17630055505245 · Model: 1600517 · Bien-Air Surgery SA
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
OSSEODUO Foot Pedal
Primary DI
17630055505245
Version / Model
1600517
Catalog Number
1600517-001
Company Name
Bien-Air Surgery SA
Labeler DUNS
481597719
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-09
Public Version
1
Public Version Date
2023-02-17
Public Version Status
New
Public Device Record Key
0d43103c-5614-4dc7-9bee-d9f3fe2d4764

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HBC Motor, Drill, Electric
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

GMDN Terms

Code Name
41264 Surgical power tool system control unit, line-powered

Identifiers

Type ID
Primary 17630055505245
Previous J00716005170011