AccessGUDID - DEVICE: Needle Guide (00841436100144)

GUDID

Device Identifier (DI) Information

Brand Name: Needle Guide
Version or Model: 8651387
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 08651387
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436100144
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 endocavity needle guide (short) with cleaning brushes (5) for use with Siemens BE9-4 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?
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
IYO	System, imaging, pulsed echo, ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K875128	000
K875240	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 1.6 Inch
Length: 4.5 Inch

Device Record Status

Public Device Record Key: bab8e3e3-da98-4788-8997-c161f45d1e23
Public Version Date: June 17, 2022
Public Version Number: 9
DI Record Publish Date: August 22, 2017