FDA.reportPublic FDA data

STFR Radial Patch

Primary DI
00862499000264
Brand
STFR Radial Patch
Company
Chitogen Inc
Model
2160
Device description
Topical hemostatic pad
Published
2024-03-18
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090100000SOFTSEAL-STFChitogen, Inc.2009-03-11QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10862499000261PackageGS11000In Commercial Distribution
00862499000264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086249900026110862499000261
00862499000264008624990002648624990002640862499000264

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.25Inch
Width1.25Inch

Regulatory Flags#

DUNS number
010307324
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10862499000261STFR Radial Patch21602024-03-18
00862499000257D-SEAL20102020-10-29
00862499000202SoftSeal21502020-10-29
10862499000254D-SEAL20102020-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10841495149518QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
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14026704930699QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
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14026704930729QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
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14026704930743QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930750QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930767QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930774QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930781QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930798QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930804QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930811QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
06970206822390Rhino Rescue Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd.QSY2026-06-22