Encompass

Basic Information

• Brand Name: Encompass
• Primary DI: 00609953597539
• Version / Model: 46942-115
• Company Name: Encompass Group, L.L.C.
• Labeler DUNS: 121788819
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-13
• Public Version: 2
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: 7fd4db59-eb3d-45fe-8ce8-64af8ce1b6ae

Device Description

COAT LAB SAFECARE LAPEL BLU M SAFECARE LC (LAPEL COLLAR) 99/1 POLY/CARBON

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15078	Laboratory apron	A garment designed to be worn by a person in the laboratory for protection from soiling or spills on the ventral (front) aspect of the body during the course of work or a procedure. It is typically made of materials resistant to substances or agents found in a laboratory. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50609953597534	GS1	CA	12	In Commercial Distribution
Primary	00609953597539	GS1

Customer Contacts

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