AccessGUDID - DEVICE: Reusable Frame, Civco/BW Stepper (Siemens Grid) (00852656007205)

GUDID

Device Identifier (DI) Information

Brand Name: Reusable Frame, Civco/BW Stepper (Siemens Grid)
Version or Model: 6053
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Best Nomos

Primary DI Number: 00852656007205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146920025 *Terms of Use

Device Description: The Civco/BW Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.

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):	No
Over the Counter (OTC):	No
Kit:	No
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
IWJ	System, Applicator, Radionuclide, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973786	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1f36104-600b-457b-b287-c8df6723c994
Public Version Date: June 17, 2022
Public Version Number: 6
DI Record Publish Date: October 31, 2016