PolyMem

Basic Information

• Brand Name: PolyMem
• Primary DI: 10735471095367
• Version / Model: SportsWrap
• Catalog Number: 9536
• Company Name: FERRIS MFG. CORP.
• Labeler DUNS: 084733682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: 70472614-d4b9-4bda-b2e7-b54bd70fba55

Device Description

5" x 36" SportsWrap by PolyMem Non-Adhesive Roll Dressing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQI	Orthosis, Limb Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46855	Wound-nonadherent dressing, permeable, non-antimicrobial	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20735471095364	GS1	Box	4	In Commercial Distribution
Primary	10735471095367	GS1
Package	30735471095361	GS1	Case	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5 in. x 36 in.

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Excursions permitted less than 55 degrees celcius but should be minimized
• Type: Storage Environment Temperature
• Temperature Range: – 30 Degrees Celsius