FDA.reportPublic FDA data

Sealk

Primary DI
10850744001361
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190600051
Device count
10
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
00850744001609BloodSTOP8322302024-07-10
00850744001364SealkSK-iX-342024-06-25
00850744001302SealkSK-iX-162024-06-25
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

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