FDA.reportPublic FDA data

InnoSEAL Hemostatic Pad

Primary DI
08800030700152
Brand
InnoSEAL Hemostatic Pad
Company
InnoTheraphy Inc.
Model
IS-H-01-20
Device description
InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.
Published
2019-05-01
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161013000InnoSEAL Hemostatic PadInnotherapy, Inc.2016-11-29QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800030700152PackageGS110In Commercial Distribution
08800030700138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800030700152088000307001528800030700152
08800030700138088000307001388800030700138

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agentA sterile, non-bioabsorbable device made of chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) intended to be applied to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) to produce a rapid haemostasis by forming a robust plug of gel which is removed after use; it is not intended for surgical use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999changkim@innotherapy.com

Regulatory Flags#

DUNS number
688398443
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
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

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Primary DI, Brand, Company table
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