AccessGUDID - DEVICE: Disposable Template, 18 Gauge, Siemens, 5 Pack (00852656007236)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Template, 18 Gauge, Siemens, 5 Pack
Version or Model: 6047
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Best Nomos

Primary DI Number: 00852656007236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146920025 *Terms of Use

Device Description: The Disposable Template, when used in conjunction with a reusable frame, 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:	Yes
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?
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
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: Yes
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
No Device Sizes

Device Record Status

Public Device Record Key: 2b27da5c-8971-4b6c-937b-2e8e6a02dbeb
Public Version Date: February 16, 2024
Public Version Number: 9
DI Record Publish Date: October 31, 2016