AccessGUDID - DEVICE: Set OSSEOUNO + S120 (J00717003000011)

GUDID

Device Identifier (DI) Information

Brand Name: Set OSSEOUNO + S120
Version or Model: 1700300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1700300-001
Company Name: Bien-Air Surgery SA

Primary DI Number: J00717003000011
Issuing Agency: HIBCC
Commercial Distribution End Date: February 10, 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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
41589	ENT shaver system	An assembly of mains electricity (AC-powered) devices designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It typically consists of a power supply transformer/control unit with operational controls, setting display, electrical connecting cables, and a rotary handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotary instruments. Some types may have dedicated software intended to provide optimal parameters for the procedure. An irrigation/suction system may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: d83bade6-7df1-4d56-815d-eaa099c4dfaf
Public Version Date: February 13, 2023
Public Version Number: 2
DI Record Publish Date: January 07, 2019