AccessGUDID - DEVICE: N/A (10841898121708)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SNDSTR10G
Company Name: INNOVATIVE HEALTH LLC

Primary DI Number: 10841898121708
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015575953 *Terms of Use

Device Description: SoundStar 3D Diagnostic Ultrasound Catheter, 10F

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?
61811	Intracardiac ultrasound imaging catheter, steerable, reprocessed	A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to an ultrasound system for image transmission/display. This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWQ	Reprocessed Intravascular Ultrasound Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170474	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
Handling Environment Humidity: less than 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 45 Degrees Celsius
Handling Environment Temperature: between -18 and 45 Degrees Celsius
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 772a26c3-af94-4c02-a871-7401e2b4daf4
Public Version Date: March 21, 2019
Public Version Number: 4
DI Record Publish Date: October 16, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 877-400-3740
Email: regulatory@innovative-health.com

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