Spectrum, Inc.

Basic Information

• Brand Name: Spectrum, Inc.
• Primary DI: 00850301007662
• Version / Model: 982-03568-000
• Catalog Number: 706931NS
• Company Name: SPECTRUM, INC.
• Labeler DUNS: 080458964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 54876b79-ed63-4e83-930a-807167f4fe27

Device Description

Equipment Drape, Tear Tip, 7" X 96", Non-sterile

Device Characteristics

• Single Use: Yes
• 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: No
• 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
MMP	Cover, barrier, protective	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61049	Instrument/equipment drape, single-use, non-sterile	A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850301007669	GS1	shipper	50	In Commercial Distribution
Primary	00850301007662	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K934630	000