6F Armadillo

GUDID 00857545008080

SelectFlex III 064 Neurovascular Access System 105 cm, 30 cm Variable Stiffness, 30cm Coating.

Q'APEL MEDICAL LLC

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00857545008080
• NIH Device Record Key: 1f37ae7d-6be2-4c1f-9159-d1b500da54db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6F Armadillo
• Version Model Number: FG 00735-05
• Company DUNS: 020937374
• Company Name: Q'APEL MEDICAL 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857545008080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230322

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

Sterilization

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

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

[00857545008080]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04