Regard

GUDID 10326053117753

AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile X Large

RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Surgical gown, single-use

• Primary Device ID: 10326053117753
• NIH Device Record Key: 9f0a5a2b-5d1c-410e-b83f-40c5870f5d4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regard
• Version Model Number: A3ISRGSTXL-REG
• Company DUNS: 134472476
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00326053117756 [Primary]
GS1	10326053117753 [Package]; Contains: 00326053117756; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192290

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-07
• Device Publish Date: 2020-05-26

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