Biopsy Bracket

Basic Information

• Brand Name: Biopsy Bracket
• Primary DI: 00841436108249
• Version / Model: 742-429-10
• Catalog Number: 742-429-10
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Labeler DUNS: 134614411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-08-22
• Public Version: 8
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: cf0988de-1ada-4687-8be5-060908230f28
• Distribution End Date: 2021-02-05

Device Description

Reusable non-sterile Infiniti Plus™ bracket for use with GE Healthcare 11L, 11L-D, 12L-RS and 12L-SC transducers

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841436108249	GS1
Unit of Use	80841436108245	GS1
Direct Marking	20841436115661	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K093713	000

Device Sizes

Type	Value	Unit	Text
Height	1.3	Inch
Length	3.1	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight
• Type: Storage Environment Temperature
• Temperature Range: 52 – 85 Degrees Fahrenheit