AccessGUDID - DEVICE: Verza Guidance System (10841436118207)

GUDID

Device Identifier (DI) Information

Brand Name: Verza Guidance System
Version or Model: 610-1504-5, 610-1504-24, 610-1504-MC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 610-1504-5, 610-1504-24, 610-1504-MC
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 10841436118207
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with (14 × 147cm) telescopically folded CIV-Flex™ cover with PEELSafe Advantage

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:	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?
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use 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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Width: 58 Inch
Length: 5.5 Inch

Device Record Status

Public Device Record Key: d84ee443-a6b5-4cf7-99f6-803a22ab5871
Public Version Date: February 16, 2024
Public Version Number: 6
DI Record Publish Date: June 21, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status
00841436118231	24	10841436118207		In Commercial Distribution
00841436118224	5	10841436118207		In Commercial Distribution
00841436118217	12	10841436118207	2022-08-03	Not in Commercial Distribution