Burkhart Tray Sleeve A 11 5/8 X 14 1/2 (500)

Basic Information

• Brand Name: Burkhart Tray Sleeve A 11 5/8 X 14 1/2 (500)
• Primary DI: 00815878020995
• Version / Model: 72720838
• Company Name: BURKHART DENTAL SUPPLY CO., THE
• Labeler DUNS: 027532357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2018-10-05
• Public Version: 1
• Public Version Date: 2018-11-05
• Public Version Status: New
• Public Device Record Key: bb258041-d926-4be5-86e5-97b0e7f0ecc7

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: 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
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61050	Dental bib	A non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10815878020992	GS1		4	In Commercial Distribution
Primary	00815878020995	GS1
Unit of Use	00815878021008	GS1

Customer Contacts

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