FDA UDI Not in Commercial Distribution 🇺🇸 United States

Bur PM2-70 80K diamond Ø0.8mm sterile

DI: J00711003660011 · Model: 1100366 · Bien-Air Surgery SA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Bur PM2-70 80K diamond Ø0.8mm sterile
Primary DI
J00711003660011
Version / Model
1100366
Catalog Number
1100366-001
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
2019-01-08
Public Version
2
Public Version Date
2023-02-09
Public Version Status
Update
Public Device Record Key
c856f452-2be8-455e-ad04-dbebf6014b5b
Distribution End Date
2023-02-08

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
No
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
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

GMDN Terms

Code Name
45527 Diamond ENT bur, single-use

Identifiers

Type ID
Primary J00711003660011