FDA.reportPublic FDA data

Suprathel® CW

Primary DI
04260184022175
Brand
Suprathel® CW
Company
Polymedics Innovations GmbH
Model
Suprathel CW 5x5
Catalog number
210505-US, 250505-US
Device description
Suprathel® CW is an absorbable, micro-porous membrane and alloplastic skin substitute for the treatment of wounds, including pressure and venous ulcers, venous stasis and diabetic ulcers, ulcers caused by mixed vascular etiologies.
Published
2024-10-11
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
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
04260184022175PackageGS15In Commercial Distribution
04260184022182PackageGS11In Commercial Distribution
04260184022137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260184022175042601840221754260184022175
04260184022182042601840221824260184022182
04260184022137042601840221374260184022137

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

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
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

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
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
04260184023332SupraSDRM®SupraSDRM 18x9311809-US2021-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977727072617Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072624Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072631Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072648Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072815SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072822SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072839SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072846SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
00854258006389Restrata(R)Acera Surgical IncQSZ2026-04-15
00854258006396Restrata MeshedAcera Surgical IncQSZ2026-04-15
00850021883072SiOxD® ORSioxmed, LLCQSZ2026-03-17
00812005030537Mirragen Advanced Wound MatrixETS Wound Care LLCQSZ2026-03-03
00817337000616HyalomatrixAnika Therapeutics, Inc.QSZ2026-02-22
00850021883003SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850021883041SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850047730305Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00852513007393Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007409Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007416Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007423Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007430Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
10850021883000SiOxD Wound MatrixSioxmed, LLCQSZ2025-02-17
00852513007362ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
00852513007379ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
00852513007386ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
04260184021598Suprathel®Polymedics Innovations GmbHQSZ2024-10-11