AccessGUDID - DEVICE: CELLXTRACT Autologous Cell and Bone Marrow Extraction (M979CXT1145S0)

GUDID

Device Identifier (DI) Information

Brand Name: CELLXTRACT Autologous Cell and Bone Marrow Extraction
Version or Model: CXT1145S 11GA X 11CM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CXT1145S
Company Name: RANFAC CORP.

Primary DI Number: M979CXT1145S0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121622872 *Terms of Use

Device Description: CELLXTRACT Autologous Cell and Bone Marrow Extraction CXT1145S 11GA X 11CM C#0002262 P/N 74271-02M

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:	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?
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
Length: 11 Centimeter
Needle Gauge: 11 Gauge

Device Record Status

Public Device Record Key: f8695c32-814e-40e1-9a74-04816e1bc448
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: March 27, 2018