AccessGUDID - DEVICE: Hobbs Biliary Amsterdam Stent Kit (M84960090)

GUDID

Device Identifier (DI) Information

Brand Name: Hobbs Biliary Amsterdam Stent Kit
Version or Model: 6009
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6009
Company Name: HOBBS MEDICAL, INC.

Primary DI Number: M84960090
Issuing Agency: HIBCC
Commercial Distribution End Date: August 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 076769355 *Terms of Use

Device Description: Biliary Amsterdam Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
43764	Polymeric biliary stent, non-bioabsorbable	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.	Active	true

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: c1cd5354-dbe4-42af-99f9-3f8ad9848ff9
Public Version Date: January 09, 2026
Public Version Number: 4
DI Record Publish Date: September 21, 2016