FDA.reportPublic FDA data

Suprathel®

Primary DI
04260184021130
Brand
Suprathel®
Company
Polymedics Innovations GmbH
Model
Suprathel 5x5
Catalog number
110505-US, 150505-US
Device description
Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treatment of wounds, split-skin donor sites, and burns as indicated hereinafter. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient’s needs.
Published
2021-09-10
Public version status
Update
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
FRODressing, Wound, Drug
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
QSZAbsorbable Synthetic Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090160000SUPRATHEL WOUND AND BURN DRESSINGPolymedics Innovations, GmbH2009-05-20QSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260184021178PackageGS15In Commercial Distribution
04260184021185PackageGS11In Commercial Distribution
04260184021130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260184021178042601840211784260184021178
04260184021185042601840211854260184021185
04260184021130042601840211304260184021130

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic wound matrix dressingA sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius22 Degrees Celsius
Storage Environment Temperature8 Degrees Celsius22 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 646-604-2771info.usa@polymedics.com

Regulatory Flags#

DUNS number
344089540
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260184021598Suprathel®Suprathel Face Mask11F001-US2024-10-11
04260184022137Suprathel® CWSuprathel CW 5x5210505-US, 250505-US2024-10-11
04260184022236Suprathel® CWSuprathel CW 9x10210910-US, 250910-US2024-10-11
04260184022557Suprathel® CWSuprathel CW 2x2210202-US, 250202-US2024-10-11
04260184021604Suprathel®Suprathel Face Mask11F001-US2024-10-11
04260184022175Suprathel® CWSuprathel CW 5x5210505-US, 250505-US2024-10-11
04260184022281Suprathel® CWSuprathel CW 9x10210910-US, 250910-US2024-10-11
04260184022571Suprathel® CWSuprathel CW 2x2210202-US, 250202-US2024-10-11
04260184021239Suprathel®Suprathel 9x10110910-US, 150910-US2021-09-17
04260184021338Suprathel®Suprathel 18x10111810-US, 151810-US2021-09-17
04260184021437Suprathel®Suprathel 18x23111823-US, 151823-US2021-09-17
04260184021543Suprathel®Suprathel Hand Size12H001-US2021-09-17
04260184023004SupraSDRM®SupraSDRM 1x1310101-US2021-09-10
04260184023028SupraSDRM®SupraSDRM 2x2310202-US2021-09-17
04260184023066SupraSDRM®SupraSDRM 5x5310505-US2021-09-17
04260184023080SupraSDRM®SupraSDRM 9x12310912-US2021-09-17
04260184023103SupraSDRM®SupraSDRM Disk1231D012-US2021-09-17
04260184023127SupraSDRM®SupraSDRM Disk1831D018-US2021-09-17
04260184023141SupraSDRM®SupraSDRM Disk2431D024-US2021-09-17
04260184023233SupraSDRM®SupraSDRM 9x9310909-US2021-09-17

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