FDA UDI Not in Commercial Distribution 🇺🇸 United States

S120 Shaver + Cable

DI: J00717003020011 · Model: 1700302 · Bien-Air Surgery SA
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
S120 Shaver + Cable
Primary DI
J00717003020011
Version / Model
1700302
Catalog Number
1700302-001
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
3
Public Version Date
2023-02-13
Public Version Status
Update
Public Device Record Key
bfbe9cad-7bc7-4359-82fb-2bc36b8201bf
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
NLY Microdebrider, Ent, High Speed, Single Use, Reprocessed
EQJ Bur, Ear, Nose And Throat

GMDN Terms

Code Name
55363 ENT shaver system handpiece

Identifiers

Type ID
Primary J00717003020011