FDA.reportPublic FDA data

QuikClot

Primary DI
30841495140502
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
New
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
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
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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

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