XSTAT

Primary DI
10851587006056
Brand
XSTAT
Company
REVMEDX, INC.
Model
XSTAT 30
Catalog number
FIN-0001-03
Device description
A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic sponges individually marked with an X-shaped radiopaque marker.
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal UseGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152624000XSTAT 30, 3-PACK, XSTAT 30, 1-PACKRevmedx, Inc.2015-12-07PGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851587006056PackageGS13In Commercial Distribution
00851587006059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085158700605610851587006056
00851587006059008515870060598515870060590851587006059

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 Diameter30Millimeter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00851587006066XSTATXSTAT-30 Gen 2FIN-0017-012019-03-28
00851587006042XSTATXSTAT 12FIN-0001-042016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851587006226XSTAT P30Revmedx, Inc.PGZ2023-01-17
00851587006066XSTATRevmedx, Inc.PGZ2019-03-28
00851587006059XSTATRevmedx, Inc.PGZ2016-09-02
00851587006042XSTATRevmedx, Inc.PGZ2016-09-02