FDA.reportPublic FDA data

QuikClot

Primary DI
00841495102899
Brand
QuikClot
Company
Z-MEDICA, LLC
Model
0289
Catalog number
0289
Device description
QuikClot Combat Gauze,CE,German,1x
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072474000QUIKCLOT EXZ-Medica Corporation2007-10-16QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50841495102894PackageGS150In Commercial Distribution
00841495102899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5084149510289450841495102894
00841495102899008414951028998414951028990841495102899

GMDN Terms#

Term, Definition table
TermDefinition
Non-organic haemostatic agentA non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(877) 750-0504quikclot-engineering@teleflex.com

Regulatory Flags#

DUNS number
079190073
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841495103018QuikClot030103012018-06-01
00841495103025QuikClot030203022018-06-01
00841495103032QuikClot030303032018-06-01
00841495104596QuikClot045904592017-09-27
00841495105104QuikClot051005102021-08-18
00841495105388QuikClot053805382021-02-09
00841495105722QuikClot057205722021-02-09
00841495106323QuikClot063206322018-06-01
00841495106330QuikClot063306332018-06-01
00841495106361QuikClot063606362021-02-10
00841495120107QuikClot201020102021-08-18
00841495140501QuikClot405040502021-08-18
00841495105340QuikClot053405342021-02-12
00841495105401QuikClot054005402021-02-12
00841495105418QuikClot054105412021-02-12
00841495105470QuikClot054705472021-02-12
00841495105487QuikClot054805482021-02-12
00841495102004QuikClot020002002021-02-10
00841495104992QuikClot049904992021-02-10
00841495105265QuikClot052605262021-02-10

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Primary DI, Brand, Company table
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00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
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04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29