AccessGUDID - DEVICE: SoundBite® Curving Tool 14 (10754026505021)

GUDID

Device Identifier (DI) Information

Brand Name: SoundBite® Curving Tool 14
Version or Model: 900-0001291
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Soundbite Medical Solutions Inc

Primary DI Number: 10754026505021
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 208993667 *Terms of Use

Device Description: The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU.

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):	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?
63211	Surgical probe/cannula bending tool	A sterile non-powered device designed to assist in the manual bending of a surgical handpiece tip, probe, or cannula to adjust the shape of the surgical device during surgery. It consists of a curved mould with a channel(s) to accept the surgical device and enable controlled manual bending. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDU	Catheter For Crossing Total Occlusions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210839	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: fcef0dea-7f67-4975-83cf-ee5b047473ca
Public Version Date: June 30, 2021
Public Version Number: 3
DI Record Publish Date: April 30, 2021