AccessGUDID - DEVICE: Needle Kit, TargetScan 3, 18 Gauge, Single (00852656007465)

GUDID

Device Identifier (DI) Information

Brand Name: Needle Kit, TargetScan 3, 18 Gauge, Single
Version or Model: 015-A237
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Best Nomos

Primary DI Number: 00852656007465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146920025 *Terms of Use

Device Description: The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.

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?
57796	Prostate biopsy needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a prostatic tissue specimen typically for histopathological examination. It is available in various diameters and has a distal tip that may be configured in various geometric forms. It is commonly used during a transrectal ultrasound (TRUS) scan. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic
FCG	Biopsy Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073399	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: 9e5a5de9-803a-4c75-bdf3-952aab4e0b66
Public Version Date: August 07, 2018
Public Version Number: 4
DI Record Publish Date: October 31, 2016