Selectiva

GUDID 00857834006797

HERAEUS MEDICAL COMPONENTS, LLC

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual

• Primary Device ID: 00857834006797
• NIH Device Record Key: 6e3f9cfe-7acd-41c9-80e5-e577b249ad1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selectiva
• Version Model Number: 3508004S-SB
• 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: false
• 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	00857834006797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033321

FDA Product Code

• DQX: Wire, Guide, Catheter

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

On-Brand Devices [Selectiva]

• 00857834006902: 18300376NW-AFB
• 00857834006896: 18300376NW-FB
• 00857834006889: 18180376NW-AFB
• 00857834006872: 18180376NW-FB
• 00857834006865: 18080280NW-ASL
• 00857834006858: 18080280NW-SL
• 00857834006841: 18060280NW-ASL
• 00857834006834: 18060280NW-SL
• 00857834006827: 3530004S-SB
• 00857834006810: 3518004S-SB
• 00857834006803: 3514504S-SB
• 00857834006797: 3508004S-SB
• 00857834006780: 3530004A-SB
• 00857834006773: 3518004A-SB
• 00857834006766: 3514504A-SB
• 00857834006759: 3508004A-SB
• 00857834006728: 3530004A
• 00857834006711: 3518004A
• 00857834006704: 3514504A
• 00857834006698: 3518004S
• 00857834006681: 3518004S
• 00857834006674: 3514504S
• 00857834006667: 3508004S
• 00857834006650: 1830004A
• 00857834006643: 1808004A
• 00857834006636: 1808004A
• 00857834006629: 1806004A
• 00857834006612: 1830004S
• 00857834006599: 1818004S
• 00857834006582: 1808004S
• 00857834006575: 1806004S