AccessGUDID - DEVICE: Verza Guidance System (00841436119474)

GUDID

Device Identifier (DI) Information

Brand Name: Verza Guidance System
Version or Model: 11506900
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11506900
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436119474
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use with Siemens 7L2 transducers

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
58248	Ultrasound imaging system tracking positioner, reusable	A metal or plastic bracket intended to be applied to a hand-held ultrasound (US) transducer for the repeatable positioning (detach from/reattach to same place) of an electromagnetic (EM) sensor and/or needle guide on the transducer. It may be used in conjunction with an EM device tracking system and is intended for applications involving needle guidance and tracking such as ablation, core tissue biopsy, fluid aspiration, therapeutic delivery and vascular access. Disposable needle guides and imaging-supportive devices (e.g., US transducer cover/gel) may be included with the positioner; the transducer and sensor are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160806	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit
Special Storage Condition, Specify: Keep Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47a169bb-f675-4e98-9a75-ddce2f110fba
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: January 22, 2021