AccessGUDID - DEVICE: Biopsy Starter Kit (00841436106139)

GUDID

Device Identifier (DI) Information

Brand Name: Biopsy Starter Kit
Version or Model: 657-030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 657-030
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436106139
Issuing Agency: GS1
Commercial Distribution End Date: November 23, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (41 x 91.5cm) CIV-Flex™ covers (5) for use with Samsung Medison CS1-4 transducer

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?
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 [?]
K093713	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
Special Storage Condition, Specify: Keep Away from Sunlight
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Height: 1.85 Inch
Length: 4.21 Inch

Device Record Status

Public Device Record Key: ff00f2cb-02b3-49a6-824f-2ebfb52fd328
Public Version Date: February 16, 2024
Public Version Number: 11
DI Record Publish Date: August 22, 2017