AccessGUDID - DEVICE: Set OSSEOSTAP + Control Unit (17630055506082)

GUDID

Device Identifier (DI) Information

Brand Name: Set OSSEOSTAP + Control Unit
Version or Model: 1700331
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1700331-001
Company Name: Bien-Air Surgery SA

Primary DI Number: 17630055506082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481597719 *Terms of Use
Previous DI: J00717003310011

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?
41264	Surgical power tool system control unit, line-powered	A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
NLY	Microdebrider, Ent, High Speed, Single Use, Reprocessed
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: 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: f4e24ec9-4d1d-4245-bcbd-fe23c77823f2
Public Version Date: February 20, 2023
Public Version Number: 1
DI Record Publish Date: February 10, 2023