FDA.reportPublic FDA data

QUIKCLOT

Primary DI
30841495149758
Brand
QUIKCLOT
Company
TELEFLEX INCORPORATED
Model
4010
Catalog number
4010
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841495149751PackageGS110In Commercial Distribution
30841495149758PackageGS110In Commercial Distribution
10841495149754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084149514975120841495149751
3084149514975830841495149758
1084149514975410841495149754

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704936011QUIKCLOTTELEFLEX INCORPORATEDPOD2026-08-27
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
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