XSTAT FIN-0017-01

GUDID 00851587006066

A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostatic sponges individually marked with an X-shaped radiopaque marker.

REVMEDX, INC.

Radiopaque woven surgical sponge, sterile Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge

• Primary Device ID: 00851587006066
• NIH Device Record Key: f746e5fe-829e-4119-b9b0-98ce3ef74c47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XSTAT
• Version Model Number: XSTAT-30 Gen 2
• Catalog Number: FIN-0017-01
• Company DUNS: 961523441
• Company Name: REVMEDX, 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: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com
• Phone: 503-218-2172
• Email: info@revmedx.com

Device Dimensions

• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter
• Outer Diameter: 28.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store device in room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851587006066 [Primary]
GS1	10851587006063 [Package]; Package: flexible pouch [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180051

FDA Product Code

• NAB: Gauze / Sponge,Nonresorbable For External 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: 2019-04-05
• Device Publish Date: 2019-03-28

On-Brand Devices [XSTAT]

• 10851587006056: A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic
• 00851587006042: A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic
• 00851587006066: A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostati