FDA.reportPublic FDA data

StatSeal®

Primary DI
00834061005274
Brand
StatSeal®
Company
BIOLIFE, L.L.C.
Model
DX627/A
Device description
StatSeal® Extra Large Disc - 1 Application
Published
2026-04-09
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

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130324000STATSEAL DISCBiolife, LLC2013-07-09QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10834061005271PackageGS124In Commercial Distribution
00834061005274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1083406100527110834061005271
00834061005274008340610052748340610052740834061005274

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter1.4Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean, dry place between 6 and 32 degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 941.360.1300customer.care@biolife.com

Regulatory Flags#

DUNS number
135872476
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00834061005236StatSeal®DT623/A2026-04-09
00834061005243StatSeal®DS624/A2026-04-09
00834061005250StatSeal®DM625/A2026-04-09
00834061005267StatSeal®DL626/A2026-04-09
00834061005281StatSeal®DA628/A2026-04-09
00834061005298StatSeal®DAP629/A2026-04-09
00834061005304StatSeal®DAR630/A2026-04-09
00834061005366StatSeal®LP636/A2026-04-09
00834061005373StatSeal®LP637/A2026-04-09
00834061000040WoundSeal®CSU004CSU0042022-01-28
00834061000231AV-Seal®DIAL001DIAL0012023-06-29
00834061000217StatSeal® DE021DE0212023-06-29
00834061000255WoundSeal®DWS001DWS0012023-06-29
00834061000019WoundSeal®WSO001WSO0012022-01-28
00834061000354WoundSeal®WSO1001CWSO1001C2022-07-07
00834061000026WoundSeal®NCW001NCW0012022-01-28
00834061000057WoundSeal®NPS001NPS0012022-01-28
00834061000064StatSeal®LP006LP0062022-01-28
00834061000071StatSeal®LP007LP0072022-01-28
00834061000101WoundSeal®QSO010QSO0102022-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841495149679QUIKCLOTTELEFLEX INCORPORATEDQSY2026-05-11
00050428142530CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDQSY2026-04-23
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
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
34026704930167QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
00810194401756AiraAIRA, LLCQSY2026-03-13