AccessGUDID - DEVICE: General Biopsy Tray (00886333217403)

GUDID

Device Identifier (DI) Information

Brand Name: General Biopsy Tray
Version or Model: CG00552
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CG00552
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333217403
Issuing Agency: GS1
Commercial Distribution End Date: January 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Custom General Biopsy Tray for University of Rochester Medical Center

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:	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?
61922	Soft-tissue biopsy procedure kit, medicated	A collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJT	Aspiration Tray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: Store in a cool place and avoid temperature extremes

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5bf2dc2-dd0b-4f9a-a36c-617519859f43
Public Version Date: January 31, 2024
Public Version Number: 2
DI Record Publish Date: July 20, 2022