Selectiva

GUDID 00857834006780

HERAEUS MEDICAL COMPONENTS, LLC

Peripheral vascular guidewire, manual

• Primary Device ID: 00857834006780
• NIH Device Record Key: 8f85aedb-b8ea-441b-8362-30e0fc764caa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selectiva
• Version Model Number: 3530004A-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	00857834006780 [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