AMG

Basic Information

• Brand Name: AMG
• Primary DI: 00850017650299
• Version / Model: JSW-CA45SMS04
• Company Name: ARROW MEDSOURCE GROUP LIMITED
• Labeler DUNS: 686378503
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-22
• Public Version: 1
• Public Version Date: 2020-06-30
• Public Version Status: New
• Public Device Record Key: 0305f9d5-a1f2-4c35-80b0-03b1f68d5664

Device Description

COVERALL ANTI-STATIC, WHITE, 45g SMS, XL

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: No
• 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
OEA	Non-Surgical Isolation Gown	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41112	Assistive coverall	A lightweight wrap (e.g., made of vinyl, nylon, or other plastic) specially designed/adapted to be used by a person with a disability to cover and protect them against precipitation (rain, snow, sleet), cold and wind, especially when using a wheelchair, pram, or sledge. The device is typically hooded and has openings to allow access to the operating and steering controls of the occupied transportation device if required.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850017650296	GS1	Case	50	In Commercial Distribution
Primary	00850017650299	GS1