Deflux Metal Needle

GUDID 00850004725023

Deflux Metal Needle

PALETTE LIFE SCIENCES, INC.

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• Primary Device ID: 00850004725023
• NIH Device Record Key: 8c024a4e-a6eb-49b0-8d57-1ea470be0b8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deflux Metal Needle
• Version Model Number: 3.7 FR x 23 G (tip) x 350 mm
• Company DUNS: 116951700
• Company Name: PALETTE LIFE SCIENCES, 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-844-350-9656
• Email: palettemc@dlss.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com
• Phone: 1-844-822-7744
• Email: support@palettelifesciences.com

Device Dimensions

• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge
• Length: 350 Millimeter
• Needle Gauge: 23 Gauge

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004725023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000029

FDA Product Code

• LMN: Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses
• LNM: Agent, Bulking, Injectable For Gastro-Urology Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-11

Devices Manufactured by PALETTE LIFE SCIENCES, INC.

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• 00850004725108 - Barrigel: 2022-12-08 Hydrogel (HA) Injectable Rectal Spacer
• 00850004725115 - Barrigel Applicator Needle: 2022-12-08 Hypodermic needles for the injection of Barrigel
• 00850004725023 - Deflux Metal Needle: 2019-03-11Deflux Metal Needle
• 00850004725023 - Deflux Metal Needle: 2019-03-11 Deflux Metal Needle
• 00850004725009 - Deflux: 2019-03-04 Deflux
• 00850004725016 - Solesta: 2019-03-04 Solesta