AccessGUDID - DEVICE: CABLE I-SURGE LED (J00716012460011)

GUDID

Device Identifier (DI) Information

Brand Name: CABLE I-SURGE LED
Version or Model: 1601246-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIEN-AIR PORTUGAL, UNIPESSOAL, LDA

Primary DI Number: J00716012460011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338234588 *Terms of Use

Device Description: The cables deliver electrical power only. Since they are not equipped with water connection, cables include a shield wire for motor grounding.

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:	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?
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBW	Controller, Foot, Handpiece And Cord

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: d73971ce-d72c-4d46-b856-4bc350492c3b
Public Version Date: May 02, 2024
Public Version Number: 1
DI Record Publish Date: April 24, 2024