FDA.reportPublic FDA data

Sealk

Primary DI
00850744001364
Brand
Sealk
Company
Lifescience Plus, Inc.
Model
SK-iX-34
Device description
"Sealk Hemostatic Dressing for ENT ,Neck%Head, thyroid 1""X3""(2.5cmX7.5cm) 10/per box"
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850744001364PrimaryGS10
10850744001361Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850744001364008507440013648507440013640850744001364
1085074400136110850744001361

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.

Regulatory Flags#

DUNS number
190600051
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850744001609BloodSTOP8322302024-07-10
00850744001302SealkSK-iX-162024-06-25
10850744001361SealkSK-iX-342024-06-25
00850744001371SealkSK-iX-222024-06-25
00850744001401BloodSTOP iXBS-iX-232024-06-25
00850744001449BloodSTOP iX Trauma MatrixTM-iX-262024-06-25
00850744001104BloodSTOPBS-10BS-102022-12-08
00850744001111BloodSTOPBS-11BS-112022-12-08
00850744001128BloodSTOPBS-12BS-122022-12-08
00850744001135BloodSTOPBS-13BS-132022-12-08
00850744001180BloodSTOPBS-MP-18BS-MP-182022-12-08
00850744001241BloodSTOP iXBS-iX-14BS-iX-142022-12-08
00850744001258BloodSTOP iXBS-iX-15BS-iX-152022-12-08
00850744001265BloodSTOP iXBS-iX-17BS-iX-172022-12-08
00850744001272BloodSTOP iXBS-iX-20BS-iX-202022-12-08
00850744001289BloodSTOP iXBS-iX-27BS-iX-272022-12-08
00850744001296BloodSTOPBS-OTC-28BS-OTC-282022-12-08
00850744001098BloodSTOPBS-09BS-092022-12-08
00850744001142BloodSTOP iXBS-iX-14NBS-iX-14N2022-12-08
00850744001395BloodSTOP iX Trauma MatrixBM-iX-24BM-iX-242022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10841495149648QUIKCLOTTELEFLEX INCORPORATEDQSY2026-04-09
14026704935892QUIKCLOTTELEFLEX INCORPORATEDQSY2026-04-09
00834061005236StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005243StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005250StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005267StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005274StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005281StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005298StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005304StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005366StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005373StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
10841495150385QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150408QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150422QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
10841495150446QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930088QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930101QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930149QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
14026704930163QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150389QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150402QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150426QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
30841495150440QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930082QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930105QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930143QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20