AccessGUDID - DEVICE: Bur PM2-70 80K Diam C Ø3.1 St (17630055503463)

GUDID

Device Identifier (DI) Information

Brand Name: Bur PM2-70 80K Diam C Ø3.1 St
Version or Model: 1100380
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1100380-001
Company Name: Bien-Air Surgery SA

Primary DI Number: 17630055503463
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481597719 *Terms of Use
Previous DI: J00711003800011

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45527	Diamond ENT bur, single-use	A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product 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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53c2541f-1fe1-47f8-bad4-9e8e38e7ab9a
Public Version Date: February 24, 2023
Public Version Number: 2
DI Record Publish Date: February 08, 2023