AccessGUDID - DEVICE: Ranfac Marrow Cellution Aspiration Needle 13GA X 5CM (00857878007088)

GUDID

Device Identifier (DI) Information

Brand Name: Ranfac Marrow Cellution Aspiration Needle 13GA X 5CM
Version or Model: 13GA X 5CM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MC-RAN-13FA
Company Name: RANFAC CORP.

Primary DI Number: 00857878007088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121622872 *Terms of Use

Device Description: Ranfac Marrow Cellution Aspiration Needle 13GA X 5CM

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: 5 Centimeter
Needle Gauge: 13 Gauge

Device Record Status

Public Device Record Key: f5c6b07c-00e1-40b9-986d-83a26968b952
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: March 07, 2018