FDA UDI In Commercial Distribution 🇺🇸 United States

Bur PM2-95 80K Diam EC Ø6.0 St

DI: 17630055504378 · Model: 1100490 · Bien-Air Surgery SA
Product Codes
5
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Bur PM2-95 80K Diam EC Ø6.0 St
Primary DI
17630055504378
Version / Model
1100490
Catalog Number
1100490-001
Company Name
Bien-Air Surgery SA
Labeler DUNS
481597719
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-08
Public Version
1
Public Version Date
2023-02-16
Public Version Status
New
Public Device Record Key
a0873712-417f-4c3f-a377-b8dbe8c62d04

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

GMDN Terms

Code Name
45527 Diamond ENT bur, single-use

Identifiers

Type ID
Package 27630055504375
Primary 17630055504378
Previous J00711004900011