Hobbs Medical Saccomanno Cell Transport System 4101

GUDID M84941012

HOBBS MEDICAL, INC.

Saccamanno solution IVD

• Primary Device ID: M84941012
• NIH Device Record Key: 68326ab2-883f-433b-8ea7-43111006ff7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hobbs Medical Saccomanno Cell Transport System
• Version Model Number: 4101
• Catalog Number: 4101
• Company DUNS: 076769355
• Company Name: HOBBS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M84941010 [Primary]
HIBCC	M84941012 [Package]; Contains: M84941010; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• LDZ: Fixative, Alcohol Containing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

Devices Manufactured by HOBBS MEDICAL, INC.

• M84960010 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960020 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960030 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960040 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960230 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960240 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960270 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960280 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.