AccessGUDID - DEVICE: Maxx Cell (00857878007453)

GUDID

Device Identifier (DI) Information

Brand Name: Maxx Cell
Version or Model: 11GA X 11CM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MXC-2
Company Name: RANFAC CORP.

Primary DI Number: 00857878007453
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121622872 *Terms of Use

Device Description: MC-RAN-11CSTS MAXX CELL WITH PREPARATION ACCESSORIES PN 74317-02M Customer# 0018407

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
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: 26d5d1a5-bed1-431f-a868-4418c1664b0f
Public Version Date: September 13, 2018
Public Version Number: 1
DI Record Publish Date: August 13, 2018