Hobbs Biliary Pigtail Stent 6104

GUDID M84961040

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 with drainage side ports. This is a single-use device.

HOBBS MEDICAL, INC.

Polymeric biliary stent, non-bioabsorbable

• Primary Device ID: M84961040
• NIH Device Record Key: e309dbb3-c7e7-486e-87f1-91e2b388e307
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hobbs Biliary Pigtail Stent
• Version Model Number: 6104
• Catalog Number: 6104
• Company DUNS: 076769355
• Company Name: HOBBS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M84961040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K834351

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-30
• Device Publish Date: 2016-09-21

On-Brand Devices [Hobbs Biliary Pigtail Stent]

• M84961090: A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duc
• M84961080: A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duc
• M84961070: A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duc
• M84961060: A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duc
• M84961050: A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duc
• M84961040: A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duc
• M84961030: A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duc
• M84961020: A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duc