FDA.reportPublic FDA data

QuikClot

Primary DI
50841495104591
Brand
QuikClot
Company
Z-MEDICA, LLC
Model
0459
Catalog number
0459
Device description
QuikClot Hemostatic Dressing, 4x4
Published
2017-09-27
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
FRODressing, Wound, Drug

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123387000QUIKCLOT HEMOSTATIC DRESSINGZ-Medica, LLC2013-04-12QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841495104597PackageGS110In Commercial Distribution
50841495104591PackageGS120In Commercial Distribution
00841495104596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084149510459730841495104597
5084149510459150841495104591
00841495104596008414951045968414951045960841495104596

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic haemostatic agent, sterileA sterile, 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 may also 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 devices to assist application may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079190073
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841495102899QuikClot028902892018-06-01
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

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