FDA UDI In Commercial Distribution 🇺🇸 United States

1.0mm S2 Mini Carbide Round Bur

DI: 17630055504873 · Model: 1502171 · Bien-Air Surgery SA
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
1.0mm S2 Mini Carbide Round Bur
Primary DI
17630055504873
Version / Model
1502171
Catalog Number
1502171-001
Company Name
Bien-Air Surgery SA
Labeler DUNS
481597719
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-27
Public Version
4
Public Version Date
2023-02-13
Public Version Status
Update
Public Device Record Key
edf1e567-fc15-40f4-b87c-c77a06f2fec0

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
EQJ Bur, Ear, Nose And Throat
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
NLY Microdebrider, Ent, High Speed, Single Use, Reprocessed

GMDN Terms

Code Name
11339 Middle ear drill bit

Identifiers

Type ID
Package 27630055504870
Primary 17630055504873