AccessGUDID - DEVICE: Bur PM2-70 80K steel Ø2.3mm sterile (J00711003560011)

GUDID

Device Identifier (DI) Information

Brand Name: Bur PM2-70 80K steel Ø2.3mm sterile
Version or Model: 1100356
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1100356-001
Company Name: Bien-Air Surgery SA

Primary DI Number: J00711003560011
Issuing Agency: HIBCC
Commercial Distribution End Date: February 08, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 481597719 *Terms of Use

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?
34848	Metal/carbide ENT bur, single-use	A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. 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
EQJ	Bur, Ear, Nose And Throat
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)

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: b748a44f-60c6-4a59-b1c7-a98852c06c2a
Public Version Date: February 09, 2023
Public Version Number: 2
DI Record Publish Date: January 08, 2019