AccessGUDID - DEVICE: Biopsy Bracket (00841436100014)

GUDID

Device Identifier (DI) Information

Brand Name: Biopsy Bracket
Version or Model: 7471134
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 07471134
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436100014
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Reusable non-sterile multi-angle bracket with cleaning brushes (5) for use with Siemens 4V1 and PH4-I 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?
60734	Needle guide, reusable	A non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.	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
Length: 2.7 Inch
Height: 1.9 Inch

Device Record Status

Public Device Record Key: aa38aef0-2a4c-490c-8194-192bc16ef5fb
Public Version Date: June 17, 2022
Public Version Number: 10
DI Record Publish Date: August 22, 2017