Prime Plus

GUDID 10818566016635

Earloop Procedure Mask, 7" x 3 5/8", Blue, 50/bx; 6 bxs/cs

SVS LLC

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use

• Primary Device ID: 10818566016635
• NIH Device Record Key: 1770b372-6e22-4f0c-ae1e-fd7e080ef7c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prime Plus
• Version Model Number: 21-2415
• Company DUNS: 831375089
• Company Name: SVS LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818566016638 [Primary]
GS1	10818566016635 [Package]; Contains: 00818566016638; Package: Case [300 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123787

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-06-15

On-Brand Devices [Prime Plus]

• 10818566016642: Earloop Procedure Mask, Yellow, 50/bx; 6bxs/cs
• 10818566016635: Earloop Procedure Mask, 7" x 3 5/8", Blue, 50/bx; 6 bxs/cs