Spectrum, Inc.

Basic Information

• Brand Name: Spectrum, Inc.
• Primary DI: 00850301007785
• Version / Model: 985-03864-000
• Catalog Number: 712806LF
• Company Name: SPECTRUM, INC.
• Labeler DUNS: 080458964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-21
• Public Version: 3
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: b78a54a2-18f2-4e7a-b686-512d3d238380

Device Description

Rapid Wrap Bandage, 6" x 5 Yards, Non-Sterile

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ITG	BANDAGE, CAST	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61223	Pressure bandage, non-latex, reusable	A strip or roll of fabric or plastic material intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., treatment of lymphoedema, venous oedema and lipoedema, support injuries associated with minor trauma), and/or to secure hot/cold packs to the body to provide heat/cold therapy. It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850301007782	GS1	Shipper	10	In Commercial Distribution
Primary	00850301007785	GS1

Customer Contacts

• Phone: [phone] ext. 3
• Email: [email protected]