Red Tunica RT-34163

GUDID 00810160810162

RedTunica™ Disposable Hypodermic Needle 25G x 5/8" - 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: 00810160810162
• NIH Device Record Key: c93483e1-4148-497e-9092-a624fc46a49f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Red Tunica
• Version Model Number: RT-34163
• Catalog Number: RT-34163
• 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: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter
• Needle Gauge: 25 Gauge
• Length: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810160810155 [Primary]
GS1	00810160810162 [Package]; Contains: 00810160810155; Package: Inner Box [100 Units]; In Commercial Distribution
GS1	00810160810179 [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

On-Brand Devices [Red Tunica]

• 00850036464815: RedTunica™ Disposable Hypodermic Needle 27G x 1-1/2" - Sterile hypodermic needles intended to
• 00810160810162: RedTunica™ Disposable Hypodermic Needle 25G x 5/8" - Sterile hypodermic needles intended to in
• 00810160810131: RedTunica™ Disposable Hypodermic Needle 23G x 1" - Sterile hypodermic needles intended to inje
• 00810160810100: RedTunica™ Disposable Hypodermic Needle 22G x 1-1/2" - Sterile hypodermic needles intended to
• 00810160810070: RedTunica™ Disposable Hypodermic Needle 21G x 1-1/2" - Sterile hypodermic needles intended to
• 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