BIOPAD

Primary DI
08054953400105
Brand
BIOPAD
Company
EURORESEARCH SRL
Model
2x2
Device description
BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure.BIOPAD® is a sponge-shaped device, constituted exclusively by lyophilized type I native heterologous collagen extracted from horse flexor tendon.When applied to a wound, BIOPAD® constitutes a barrier for the wound against exogenous infective agents.BIOPAD® is the ideal first-aid means to control minor bleeding. The device may be used by healthcare professionals. BIOPAD® is supplied sterile and for one-time use only.
Published
2022-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K040283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040283000BIOPADEuroresearch Srl2005-07-22QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054953400105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054953400105080549534001058054953400105

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429605488
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054953400112BIOPAD4x42022-12-28

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Primary DI, Brand, Company table
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