FDA UDI Not in Commercial Distribution 🇺🇸 United States

Set OSSEOUNO + S120

DI: J00717003000011 · Model: 1700300 · Bien-Air Surgery SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Set OSSEOUNO + S120
Primary DI
J00717003000011
Version / Model
1700300
Catalog Number
1700300-001
Company Name
Bien-Air Surgery SA
Labeler DUNS
481597719
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-07
Public Version
2
Public Version Date
2023-02-13
Public Version Status
Update
Public Device Record Key
d83bade6-7df1-4d56-815d-eaa099c4dfaf
Distribution End Date
2023-02-10

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

GMDN Terms

Code Name
41589 ENT shaver system

Identifiers

Type ID
Primary J00717003000011