AccessGUDID - DEVICE: THUNDERBEAT Open Fine Jaw Type X (04953170435829)

GUDID

Device Identifier (DI) Information

Brand Name: THUNDERBEAT Open Fine Jaw Type X
Version or Model: TB-0009OFX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N5768340
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170435829
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:	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?
64246	Endoscopic electrosurgical/ultrasonic surgical system instrument	A hand-held, endoscopic device intended to be used as part of an electrosurgical/ultrasonic system to deliver both: 1) ultrasonic energy; and 2) bipolar electrosurgical current for fragmenting, cutting and coagulation of soft-tissues during endoscopic (e.g., laparoscopic) surgery; it may in addition be intended for open surgery. It includes a handpiece/holder with controls and a long, thin shaft with distal electrodes and an ultrasonic tip, and may include a lumen for suction/irrigation; it does not include an ultrasonic transducer. It is available in a variety of forms (e.g., forceps, rigid probe). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
LFL	Instrument, Ultrasonic Surgical

FDA Premarket Submission

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

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: 3e07f3a5-0cff-4fb3-934f-f7b8fd87198b
Public Version Date: April 22, 2024
Public Version Number: 2
DI Record Publish Date: August 09, 2023