AccessGUDID - DEVICE: PenBone (08056138585775)

GUDID

Device Identifier (DI) Information

Brand Name: PenBone
Version or Model: PI1535/100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PI1535/100
Company Name: M.D.L. S.R.L.

Primary DI Number: 08056138585775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 447228586 *Terms of Use

Device Description: DISPOSABLE BONE BIOPSY NEEDLE FOR ILIAC CREST MARROW ASPIRATION, LIGHT VERSION 15G X 35/100 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
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
DWO	Needle, Biopsy, Cardiovascular

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 15 Gauge
Device Size Text, specify: length from 35 mm to 100 mm

Device Record Status

Public Device Record Key: f7df5127-6b78-4af6-a2a2-50d6260a8869
Public Version Date: May 27, 2021
Public Version Number: 2
DI Record Publish Date: May 14, 2021