MEDICOM DISTECH

Basic Information

• Brand Name: MEDICOM DISTECH
• Primary DI: 20686864049337
• Version / Model: 7283
• Catalog Number: 7283
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-01-13
• Public Version: 1
• Public Version Date: 2019-02-13
• Public Version Status: New
• Public Device Record Key: d3c2767a-e6c7-4341-ab05-a6952119075e

Device Description

MEDICOM DISTECH DENTAL BIBS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
KHR	ABSORBER, SALIVA, PAPER	Dental	872.6050	1

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
Primary	20686864049337	GS1
Unit of Use	00686864049333	GS1

Customer Contacts

• Phone: [phone] ext. 2309
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry place