Red Tunica RT-34145

GUDID 00810160810018

RedTunica™ Disposable Hypodermic Needle 18G x 1-1/2" - Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from body parts below the skin's surface.

Rodimedi & Associates, Inc.

Hypodermic needle, single-use

• Primary Device ID: 00810160810018
• NIH Device Record Key: 60c44aec-367f-4894-bc48-6a8e964da200
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Red Tunica
• Version Model Number: RT-34145
• Catalog Number: RT-34145
• Company DUNS: 785417726
• Company Name: Rodimedi & Associates, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: +1 (888) 315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM

Device Dimensions

• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter
• Needle Gauge: 18 Gauge
• Length: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810160810001 [Primary]
GS1	00810160810018 [Package]; Contains: 00810160810001; Package: Inner Box [100 Units]; In Commercial Distribution
GS1	00810160810025 [Package]; Package: Case [10000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172938

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2024-06-24
• Device Publish Date: 2024-06-14

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• 00810160810049: RedTunica™ Disposable Hypodermic Needle 20G x 1-1/2" - Sterile hypodermic needles intended to
• 00810160810018: RedTunica™ Disposable Hypodermic Needle 18G x 1-1/2" - Sterile hypodermic needles intended to