FDA.reportPublic FDA data

PolyMem

Primary DI
10735471095480
Brand
PolyMem
Company
FERRIS MFG. CORP.
Model
SportsWrap
Catalog number
9548
Device description
"5"" x 48"" SportsWrap by PolyMem Non-Adhesive Roll Dressing"
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20735471095487PackageGS13In Commercial Distribution
30735471095484PackageGS12In Commercial Distribution
10735471095480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2073547109548720735471095487
3073547109548430735471095484
1073547109548010735471095480

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. 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
Premarket exempt
true
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
10735471017888PolyMemWIC Silver17882020-08-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327129MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327136MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327143MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327150MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327167MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327174MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327181MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327198MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327204MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327211MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327228MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327235MEDIMEDI MANUFACTURING, INC.IQI2026-07-20