Aspire Introducer Needle 100-0035

GUDID 10857808005419

Introducer Needle

ASPIRE BARIATRICS, INC.

Non-vascular catheter introduction set

• Primary Device ID: 10857808005419
• NIH Device Record Key: dc9b683f-dd5a-4429-b8fd-4dea8a4ee933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspire Introducer Needle
• Version Model Number: 100-0035
• Catalog Number: 100-0035
• Company DUNS: 026281163
• Company Name: ASPIRE BARIATRICS, INC.
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge
• Length: 10 Centimeter
• Needle Gauge: 17 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	10857808005419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180725

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-03-20
• Device Publish Date: 2018-08-13

Devices Manufactured by ASPIRE BARIATRICS, INC.

• 10857808005419 - Aspire Introducer Needle: 2024-03-20Introducer Needle
• 10857808005419 - Aspire Introducer Needle: 2024-03-20 Introducer Needle
• 10857808005891 - Aspire Venting Tube Kit: 2020-04-20 Aspire Venting Tube Kit
• 10857808005013 - AspireAssist A-Tube Pack: 2019-10-07 A-Tube Pack
• 10857808005020 - AspireAssist A-Tube Kit: 2019-10-07 AspireAssist A-Tube Kit
• 10857808005037 - AspireAssist A-Tube Kit: 2019-10-07 AspireAssist A-Tube Kit
• 10857808005044 - AspireAssist A-Tube Kit: 2019-10-07 AspireAssist A-Tube Kit
• 10857808005471 - AspireAssist A-Tube Kit: 2019-10-07 AspireAssist A-Tube Kit