AccessGUDID - DEVICE: MAXX-CELL-3 (00857878007316)

GUDID

Device Identifier (DI) Information

Brand Name: MAXX-CELL-3
Version or Model: 11GA X 11CM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MXC-3
Company Name: RANFAC CORP.

Primary DI Number: 00857878007316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121622872 *Terms of Use

Device Description: MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 15CM RJN-815 PN 74408-01M

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?
60478	Bone access cannula	A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. 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 [?]
K150563	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 11 Gauge
Length: 11 Centimeter
Needle Gauge: 8 Gauge
Length: 15 Centimeter

Device Record Status

Public Device Record Key: 4d7cf7ad-e9b1-46d5-88f8-5b0e6d975351
Public Version Date: September 17, 2024
Public Version Number: 1
DI Record Publish Date: September 09, 2024