Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

GUDID 08500019130009

Mini-Kit, 70mm w/ filter

Solo-Dex, Inc

Peripheral nerve-block sharp needle

• Primary Device ID: 08500019130009
• NIH Device Record Key: 5b04139a-6b51-40a9-b15c-c52fdd65c9d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
• Version Model Number: 500014
• Company DUNS: 118663297
• Company Name: Solo-Dex, 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500019130009 [Primary]
GS1	18500019130006 [Package]; Package: Box of 10 [10 Units]; In Commercial Distribution
GS1	28500019130003 [Package]; Package: Box of 100 [100 Units]; In Commercial Distribution
HIBCC	B372500001011 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151072

FDA Product Code

• BSP: Needle, Conduction, Anesthetic (W/Wo Introducer)

Sterilization

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

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

[08500019130009]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-15
• Device Publish Date: 2018-09-20

On-Brand Devices [Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit ]

• 08500019130009: Mini-Kit, 70mm w/ filter
• 10850001913277: Needle 20 gauge, Catheter 4 French X 100 mm Mini Kit (50cm Extension, non-stimulation)
• 10850001913154: Needle 20 gauge, Catheter 4 French X 150 mm Mini Kit
• 10850001913109: Mini-Kit, 100mm w/ filter
• 10850001913048: Needle 20 gauge, Catheter 4 French X 40 mm Mini Kit
• 00850001913355: Needle 20 gauge, Catheter 4 French X 135 mm Mini Kit