AccessGUDID - DEVICE: BIOPSYBELL (08033860036317)

GUDID

Device Identifier (DI) Information

Brand Name: BIOPSYBELL
Version or Model: BONE MARROW MSC ASPIRATION KIT-MARROW-STEM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MWS1110C-US
Company Name: BIOPSYBELL SRL

Primary DI Number: 08033860036317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438746708 *Terms of Use

Device Description: ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE

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):	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?
47612	Bone marrow explant needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously explant bone marrow (explant is the collection and transfer of living bone marrow from its natural site to a new site, or to a culture medium). The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the sternum, hip bone, or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. 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 [?]
K203397	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
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Centimeter
Needle Gauge: 11 Gauge

Device Record Status

Public Device Record Key: 9097e2fb-8309-4fa2-86af-94605c8e5cb6
Public Version Date: February 25, 2021
Public Version Number: 1
DI Record Publish Date: February 17, 2021