AccessGUDID - DEVICE: Bone Marrow Tray (00886333217380)

GUDID

Device Identifier (DI) Information

Brand Name: Bone Marrow Tray
Version or Model: CB0370
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CB0370
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333217380
Issuing Agency: GS1
Commercial Distribution End Date: January 20, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Custom Bone Marrow Tray for Hackensack University 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?
46350	Bone marrow biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. 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: Keep dry and away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3f97e74-6561-4449-83bb-2f68707d7ae4
Public Version Date: January 21, 2025
Public Version Number: 2
DI Record Publish Date: July 18, 2022