Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 10326053116336
• Version / Model: UR1064
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Labeler DUNS: 945020902
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-05
• Public Version: 2
• Public Version Date: 2020-08-27
• Public Version Status: Update
• Public Device Record Key: b7df500a-3588-4103-9e0e-7bdba1e1d604
• Distribution End Date: 2020-08-26

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDE	Laparoscopy Kit	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44096	Laparoscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20326053116333	GS1		3	Not in Commercial Distribution	2020-08-26
Primary	10326053116336	GS1