XSTAT

Basic Information

• Brand Name: XSTAT
• Primary DI: 00851587006066
• Version / Model: XSTAT-30 Gen 2
• Catalog Number: FIN-0017-01
• Company Name: REVMEDX, INC.
• Labeler DUNS: 961523441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-28
• Public Version: 2
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: f746e5fe-829e-4119-b9b0-98ce3ef74c47

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	878.4014	1
PGZ	Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use	General, Plastic Surgery	878.4452	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851587006066	GS1
Package	10851587006063	GS1	flexible pouch	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180051	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	28.5	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store device in room temperature