AccessGUDID - DEVICE: SuperCore Advantage™ (00886333226139)

GUDID

Device Identifier (DI) Information

Brand Name: SuperCore Advantage™
Version or Model: 801120200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 801120200
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333226139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: SuperCore Advantage™ Semi-Automatic Biopsy Instrument 20ga x 20cm (Use with Optional Co-Axial Cannula Bundle: 19ga x 15.9cm & Cannula Bundle Catalog Number: MCXB2020BX)

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):	Yes
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?
22726	End-cut biopsy gun handpiece/needle	A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	Instrument, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213232	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
Special Storage Condition, Specify: Keep dry and away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20ga x 20cm

Device Record Status

Public Device Record Key: 2bc19d7a-11ae-4a00-ac29-c31b4055405b
Public Version Date: December 22, 2022
Public Version Number: 1
DI Record Publish Date: December 14, 2022