AccessGUDID - DEVICE: Busse Hospital Disposables (00849233013834)

GUDID

Device Identifier (DI) Information

Brand Name: Busse Hospital Disposables
Version or Model: 988
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 988
Company Name: ROBERT BUSSE & CO., INC.

Primary DI Number: 00849233013834
Issuing Agency: GS1
Commercial Distribution End Date: July 15, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 002418234 *Terms of Use

Device Description: Safety Deluxe bone Marrow Biopsy/Aspiration Tray with Snare-it marrow acquisition & Aspiration needle

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":	Yes
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?
16833	Bone marrow biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PRV	Gastro-Urology Biopsy Kit

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ff9e2d5-7250-4ab7-ab40-9ccba1675687
Public Version Date: July 18, 2022
Public Version Number: 5
DI Record Publish Date: September 02, 2016