PERFORMANCE HEALTH

Basic Information

• Brand Name: PERFORMANCE HEALTH
• Primary DI: 00840216112186
• Version / Model: A34912
• Company Name: Asp Global, LLC
• Labeler DUNS: 080361159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-11
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: febee182-1bd7-4ac6-9532-16070fb2f103

Device Description

R-Stretch Elasticized Loop, Beige, 1" x 25 yd. (2.5cm x 23m)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
IPM	Cover, Limb	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64099	Splint padding/strapping material	A sheet of flexible multi-layered material intended to be used to pad or strap a splint to an appendage, typically for use on a paediatric patient. It is made of layers of cotton, nylon and non-latex rubber (e.g., neoprene) and can be cut to a required size. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840216112186	GS1