AccessGUDID - DEVICE: Hobbs Pusher Catheter (M84961340)

GUDID

Device Identifier (DI) Information

Brand Name: Hobbs Pusher Catheter
Version or Model: 6134
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6134
Company Name: HOBBS MEDICAL, INC.

Primary DI Number: M84961340
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076769355 *Terms of Use

Device Description: A sterile device inserted through a compatible flexible endoscope to aid in implanting a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is commonly made of polytetrafluoroethylene (PTFE). This is a single-use device.

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?
46689	Endoscopic stent-placement system	An assembly of sterile devices inserted through a compatible flexible endoscope to implant a stent, typically into a pancreatic or biliary duct in order to maintain patency. It typically consists of a positioning catheter onto which the stent is loaded, a guiding device (commonly known as an introducer or guidewire) that aids the initial placement of the stent, and a pusher catheter that holds the stent in place during withdrawal of the other component devices. It is commonly made of polytetrafluoroethylene (PTFE) [Teflon], or polyethylene (PE). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGE	Catheter, Biliary, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K834351	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
No Device Sizes

Device Record Status

Public Device Record Key: 3a5c984f-9754-44be-b8b8-e912d84ee1d5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016