SCOTT'S FULL CHAIR COVER 29" X 80" (125/bx)

Basic Information

• Brand Name: SCOTT'S FULL CHAIR COVER 29" X 80" (125/bx)
• Primary DI: D77810750071
• Version / Model: 107-5007
• Catalog Number: 107-5007
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 125
• Record Status: Published
• Publish Date: 2021-02-27
• Public Version: 1
• Public Version Date: 2021-03-08
• Public Version Status: New
• Public Device Record Key: b42904ac-843e-4f94-9ac7-b6b2a2ab5d25

Device Description

CHAIR COVERS (125/box) Dimensions: 29" x 80", Color: Clear, Covers: Full Chair; For more information: https://www.scottsdental.com/catalog/product/view/id/24005/s/chair-covers-scott-s-select/

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
PEM	Dental barriers and sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D77810750070	HIBCC
Primary	D77810750071	HIBCC

Customer Contacts

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