FDA.reportPublic FDA data

D-SEAL

Primary DI
10862499000254
Brand
D-SEAL
Company
Chitogen Inc
Model
2010
Device description
hemostatic dressing
Published
2020-10-29
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
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
10862499000254PackageGS1100In Commercial Distribution
00862499000257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086249900025410862499000254
00862499000257008624990002578624990002570862499000257

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
Length1Inch
Width1Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7635595670info@chitogen.com

Regulatory Flags#

DUNS number
010307324
Device count
1
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
true
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
00862499000264STFR Radial Patch21602024-03-18
10862499000261STFR Radial Patch21602024-03-18
00862499000257D-SEAL20102020-10-29
00862499000202SoftSeal21502020-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
10841495149457QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149464QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149471QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149488QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149495QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149501QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149518QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149549QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149563QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149587QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149600QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149624QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930644QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930651QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17