FDA.reportPublic FDA data

StatSeal®

Primary DI
00834061005373
Brand
StatSeal®
Company
BIOLIFE, L.L.C.
Model
LP637/A
Device description
StatSeal® Advanced Powder - 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
K070520000
K080210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070520000PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)Biolife, LLC2007-10-23QSY
K080210000PRO QR ADVANCED FORMULA POWDERBiolife, LLC2009-02-10QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10834061005370PackageGS124In Commercial Distribution
00834061005373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1083406100537010834061005370
00834061005373008340610053738340610053730834061005373

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.

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
00834061005274StatSeal®DX627/A2026-04-09
00834061005281StatSeal®DA628/A2026-04-09
00834061005298StatSeal®DAP629/A2026-04-09
00834061005304StatSeal®DAR630/A2026-04-09
00834061005366StatSeal®LP636/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
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06970206822390Rhino Rescue Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd.QSY2026-06-22