FDA UDI In Commercial Distribution 🇺🇸 United States

HS Diam. Burr, Ø2.0x70, 80k

DI: 17630055507003 · Model: 360220 ES · Bien-Air Surgery SA
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
HS Diam. Burr, Ø2.0x70, 80k
Primary DI
17630055507003
Version / Model
360220 ES
Catalog Number
1100559-001
Company Name
Bien-Air Surgery SA
Labeler DUNS
481597719
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-22
Public Version
1
Public Version Date
2023-03-02
Public Version Status
New
Public Device Record Key
170da434-2239-4aaf-8441-db82e778d72c

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
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
HBC Motor, Drill, Electric
NLY Microdebrider, Ent, High Speed, Single Use, Reprocessed
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
EQJ Bur, Ear, Nose And Throat

GMDN Terms

Code Name
45527 Diamond ENT bur, single-use

Identifiers

Type ID
Package 27630055507000
Primary 17630055507003