Bard Snare OUS

GUDID 00857834006551

HERAEUS MEDICAL COMPONENTS, LLC

Vena cava filter extraction/repositioning kit

• Primary Device ID: 00857834006551
• NIH Device Record Key: 73bb64e0-41c7-4305-a4c4-d0ca9aa51fba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bard Snare OUS
• Version Model Number: SRK35
• Company DUNS: 080645456
• Company Name: HERAEUS MEDICAL COMPONENTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857834006551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152560

FDA Product Code

• MMX: Device, Percutaneous Retrieval

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

Devices Manufactured by HERAEUS MEDICAL COMPONENTS, LLC

• 00857834006605 - Odyssey Micro Catheter: 2019-04-09
• 00857834006933 - Odyssey Micro Catheter: 2019-04-09
• 00857834006070 - ERCP: 2018-10-05
• 00857834006087 - ERCP: 2018-10-05
• 00857834006094 - ERCP: 2018-10-05
• 00857834006100 - ERCP: 2018-10-05
• 00857834006117 - ERCP: 2018-10-05
• 00857834006124 - ERCP: 2018-10-05