Regard

GUDID 20326053113431

RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 20326053113431
• NIH Device Record Key: 4a44150c-3c7a-43f4-9455-92c8afa699a6
• Commercial Distribution Discontinuation: 2020-08-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Regard
• Version Model Number: GS0904
• Company DUNS: 945020902
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10326053113434 [Primary]
GS1	20326053113431 [Package]; Contains: 10326053113434; Package: [3 Units]; Discontinued: 2020-08-26; Not in Commercial Distribution

FDA Product Code

• LRO: General Surgery Tray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-08-27
• Device Publish Date: 2017-10-06

On-Brand Devices [Regard]

• 20326053113226: HT0870
• 10326053117616: AAMI LEVEL 1, PROCEDURE MASK, EARLOOP, GREEN, NON STERILE, UNIVERSAL SIZE
• 10326053117449: GOWN ISOL PULLOVER AAMI2 2XL
• 10326053117432: GOWN ISOL PULLOVER AAMI2 XL
• 10326053117425: GOWN ISOL PULLOVER AAMI2 UNIV
• 10326053117746: Goggles Without Ventilation, Universal Size
• 20326053113431: GS0904
• 10326053117760: AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile XX Large
• 10326053117753: AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile X Large