FDA.reportPublic FDA data

PolyMem

Primary DI
10735471017888
Brand
PolyMem
Company
FERRIS MFG. CORP.
Model
WIC Silver
Catalog number
1788
Device description
"8"" x 8"" WIC Silver Cavity Wound Filler"
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
KMFBandage, Liquid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
KMFBandage, LiquidGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20735471017885PackageGS15In Commercial Distribution
30735471017882PackageGS12In Commercial Distribution
10735471017888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2073547101788520735471017885
3073547101788230735471017882
1073547101788810735471017888

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, antimicrobialA non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent), and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Excursions permitted less than 55 degrees celcius but should be minimized
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8007659636info@polymem.com

Regulatory Flags#

DUNS number
084733682
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10735471024695PolyMemSilicone Border24692026-01-14
20735471024692PolyMemSilicone Border24692026-01-14
10735471013316PolyMemWIC Silver13312020-08-31
10735471013330PolyMemWIC Silver13332020-08-31
10735471018144PolyMemWIC Silver18142020-08-31
10735471024664PolyMemSilicone Border24662022-12-28
10735471024992PolyMemSilicone Border24992022-12-28
10735471012494PolyMemSilicone Silver Border12492021-03-31
10735471012890PolyMemSilicone Silver Border12892021-03-31
10735471024398PolyMemSilicone Border24392021-03-31
10735471028396PolyMemSilicone Border28392021-03-31
20735471012491PolyMemSilicone Silver Border12492021-03-31
20735471012897PolyMemSilicone Silver Border12892021-03-31
20735471024395PolyMemSilicone Border24392021-03-31
20735471028393PolyMemSilicone Border28392021-03-31
10735471053336PolyMemShapes53332020-08-31
10735471053350PolyMemShapes53352020-08-31
10735471002037PolyMemPolyMem2032020-08-31
10735471002303PolyMemMAX02302020-08-31
10735471004000PolyMemNursicare400-US2020-08-31

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