Closed Needle Guide LNGC-2022

GUDID 20813079020411

20/22ga (0.9/0.7mm)

REMINGTON MEDICAL, INC.

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• Primary Device ID: 20813079020411
• NIH Device Record Key: 3044c33e-f4f1-4a90-8598-d0a8241c0ba7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Closed Needle Guide
• Version Model Number: LNGC-2022
• Catalog Number: LNGC-2022
• Company DUNS: 788472314
• Company Name: REMINGTON MEDICAL, INC.
• Device Count: 2
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com

Device Dimensions

• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813079020417 [Primary]
GS1	10813079020414 [Package]; Contains: 00813079020417; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	20813079020411 [Package]; Contains: 10813079020414; Package: Shipping Carton [10 Units]; In Commercial Distribution
GS1	80813079020413 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983621

FDA Product Code

• IZH: System, x-ray, mammographic

Sterilization

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

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [Closed Needle Guide]

• 20813079020411: 20/22ga (0.9/0.7mm)
• 10813079020407: 14ga (2.1mm)