american catheter CORP

GUDID B80291000

laparoscopic cholangiogram catheter

American Catheter Corp.

Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use

• Primary Device ID: B80291000
• NIH Device Record Key: 7994c7bb-bced-4667-90e2-6561621e05b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: american catheter CORP
• Version Model Number: 9100
• Company DUNS: 117322103
• Company Name: American Catheter Corp.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B80291000 [Primary]

FDA Product Code

• GBZ: Catheter, Cholangiography

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20