Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813023686
• Version / Model: 9508255
• Catalog Number: 9508255
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-06-05
• Public Version: 1
• Public Version Date: 2019-06-13
• Public Version Status: New
• Public Device Record Key: e1eb2000-7f0c-4ab5-ab91-a9f153b33e65

Device Description

SLEEVE LO-SPD 11/2X8

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: Yes
• 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
NRU	CHAIR, DENTAL, WITHOUT OPERATIVE UNIT	Dental	872.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63712	Medical equipment drape, single-use, non-sterile	A non-sterile 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 not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20889813023680	GS1		36	In Commercial Distribution
Primary	00889813023686	GS1
Unit of Use	00889813023679	GS1

Customer Contacts

• Phone: [phone] ext. 6431
• Email: [email protected]