AccessGUDID - DEVICE: GALACTOGRAPHY STRAIGHT INFUSION, 31 GA (M9796800807M0)

GUDID

Device Identifier (DI) Information

Brand Name: GALACTOGRAPHY STRAIGHT INFUSION, 31 GA
Version or Model: 31 Gauge
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31G-END
Company Name: RANFAC CORP.

Primary DI Number: M9796800807M0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121622872 *Terms of Use

Device Description: GALACTOGRAPHY STRAIGHT INFUSION, 31 GA, 31G-END PN68008-07M

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?
46669	Breast ductography cannula	A thin, sterile, semi-rigid or rigid metal tube that is inserted into the nipple of the female breast to inject a contrast medium into the lactiferous ducts to enhance their visualization during a radiographic procedure. It is typically made of high-grade stainless steel and is designed with a blunt distal tip; it has a connector at the proximal end for attachment to a device that propels the contrast medium. This metal tube is typically used to help define the cause of nipple discharge from intraductal abnormalities such as neoplasms, ductal ectasia, or fibrocystic changes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCB	Needle, Catheter

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: 31 Gauge

Device Record Status

Public Device Record Key: 68d95b2f-bb6a-4339-b23b-2e077d1c70ce
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 09, 2017