FDA.reportPublic FDA data

XSTAT

Primary DI
00851587006066
Brand
XSTAT
Company
Revmedx, Inc.
Model
XSTAT-30 Gen 2
Catalog number
FIN-0017-01
Device description
A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostatic sponges individually marked with an X-shaped radiopaque marker.
Published
2019-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use
PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1
PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal UseGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180051000XSTAT 30, 1-PackRevmedx, Inc.2018-05-18PGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851587006063PackageGS11In Commercial Distribution
00851587006066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085158700606310851587006063
00851587006066008515870060668515870060660851587006066

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical sponge, sterileA non-medicated sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter28.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store device in room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
503-218-2172info@revmedx.com

Regulatory Flags#

DUNS number
961523441
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851587006073XGAUZE Trauma PadFIN-0019-03FIN-0019-032026-02-25
00851587006097AirWrap XLFIN-0005-022026-02-25
00851587006059XSTATXSTAT 30FIN-0001-032016-09-02
00851587006080AirWrapFIN-0005-01FIN-0005-012023-01-17
00851587006226XSTAT P30FIN-0017-21FIN-0017-212023-01-17
00851587006042XSTATXSTAT 12FIN-0001-042016-09-02
10851587006056XSTATXSTAT 30FIN-0001-032016-09-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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