FDA.reportPublic FDA data

SupraSDRM®

Primary DI
04260184023004
Brand
SupraSDRM®
Company
Polymedics Innovations GmbH
Model
SupraSDRM 1x1
Catalog number
310101-US
Device description
SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.
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
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSZAbsorbable Synthetic Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170213000SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH2017-06-28QSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260184023011PackageGS11In Commercial Distribution
04260184023004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260184023011042601840230114260184023011
04260184023004042601840230044260184023004

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 Celsius25 Degrees Celsius

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
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