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
Primary Device ID00851587006066
NIH Device Record Keyf746e5fe-829e-4119-b9b0-98ce3ef74c47
Commercial Distribution StatusIn Commercial Distribution
Brand NameXSTAT
Version Model NumberXSTAT-30 Gen 2
Catalog NumberFIN-0017-01
Company DUNS961523441
Company NameREVMEDX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com
Phone503-218-2172
Emailinfo@revmedx.com

Device Dimensions

Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter
Outer Diameter28.5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store device in room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100851587006066 [Primary]
GS110851587006063 [Package]
Package: flexible pouch [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NABGauze / Sponge,Nonresorbable For External Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-05
Device Publish Date2019-03-28

On-Brand Devices [XSTAT]

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

Trademark Results [XSTAT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XSTAT
XSTAT
85475849 4584835 Live/Registered
RevMedx, Inc.
2011-11-17
XSTAT
XSTAT
73671262 1512407 Dead/Cancelled
WINSTANDLEY & ASSOCIATES, INC.
1987-07-09
XSTAT
XSTAT
73517804 not registered Dead/Abandoned
MING TELECOMPUTING INC.
1985-01-16

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