FDA.reportPublic FDA data

SupraSDRM®

Primary DI
04260184023134
Brand
SupraSDRM®
Company
Polymedics Innovations GmbH
Model
SupraSDRM Disk18
Catalog number
31D018-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
2021-09-17
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
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
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
04260184023134PackageGS11In Commercial Distribution
04260184023127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260184023134042601840231344260184023134
04260184023127042601840231274260184023127

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

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
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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