AccessGUDID - DEVICE: CyberWand Probe Set (H891CWRBP1)

GUDID

Device Identifier (DI) Information

Brand Name: CyberWand Probe Set
Version or Model: CW-RBP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CYBERSONICS INC

Primary DI Number: H891CWRBP1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 943561522 *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:	Yes
Prescription Use (Rx):	No
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?
37138	Ultrasonic lithotripsy system handpiece	A hand-held ultrasonic device that creates a high frequency vibration through a transducer, when electrical energy is applied to its piezo-ceramic elements, which is transmitted to stones (calculi) via a coaxially attached metal probe, fragmenting the stones. The electrical energy is supplied and regulated by an ultrasonic lithotripsy generator. The stone fragments are removed through the lumen of the probe and transducer by a suction system which is facilitated through the ultrasonic lithotripsy system. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFK	Lithotriptor, Electro-Hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120303	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: d85982b3-d91c-4f50-8b93-7d05785f7573
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H891CWRBPBX3	3	H891CWRBP1		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES