FDA.reportPublic FDA data

QuikClot

Primary DI
00841495140501
Brand
QuikClot
Company
Z-MEDICA, LLC
Model
4050
Catalog number
4050
Device description
"QuikClot Control+ Hemostatic Dressing 5"" x 5"" 4-ply"
Published
2021-08-18
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
PODTemporary, Internal Use Hemostatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PODTemporary, Internal Use HemostaticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160012000D2 DressingZ-Medica, LLC2017-06-30POD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841495140502PackageGS110In Commercial Distribution
50841495140506PackageGS118In Commercial Distribution
00841495140501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084149514050230841495140502
5084149514050650841495140506
00841495140501008414951405018414951405010841495140501

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
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
00841495105340QuikClot053405342021-02-12
00841495105401QuikClot054005402021-02-12
00841495105418QuikClot054105412021-02-12
00841495105470QuikClot054705472021-02-12
00841495105487QuikClot054805482021-02-12
00841495102004QuikClot020002002021-02-10
00841495104992QuikClot049904992021-02-10
00841495105265QuikClot052605262021-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841495149686QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
10841495149709QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
10841495149723QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
10841495149747QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
30841495149680QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
20841495149706QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
20841495149720QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
20841495149744QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-18
10841495149693QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149716QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149730QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149754QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149778QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936028QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936189QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936202QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936226QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
14026704936240QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
20841495149690QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
20841495149713QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
20841495149737QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
30841495149758QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
20841495149775QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
34026704936022QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
24026704936186QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
34026704936206QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
24026704936223QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
24026704936247QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-10
10841495149655QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-06
30841495149659QUIKCLOTTELEFLEX INCORPORATEDPOD2026-02-06