AccessGUDID - DEVICE: THUNDERBEAT Transducer (04953170306778)

GUDID

Device Identifier (DI) Information

Brand Name: THUNDERBEAT Transducer
Version or Model: TD-TB400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170306778
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *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":	Yes
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?
61846	Ultrasonic surgical system transducer	A hand-held component of an ultrasonic surgical system intended to be connected to a system holder/tip or combined holder/tip, whereby it is designed to convert high frequency electrical current from a generator into an ultrasonic oscillation, to fragment hard and/or soft tissue cells for cutting and/or coagulating tissue during surgery (e.g., arthroscopic); it is not dedicated to dental applications. It may be referred to as a handpiece however it does not include controls and cannot be directly connected to the tip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
LFL	Instrument, ultrasonic surgical
KNS	Unit, electrosurgical, endoscopic (with or without accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211838	000

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: 8dd9e6e3-328e-4d53-8364-d9bf6d58e7f9
Public Version Date: April 22, 2024
Public Version Number: 4
DI Record Publish Date: September 21, 2016