SoloFit SF-4XXXL-EL

GUDID 00854150007255

Solofit Critical Zone AAMI IV Gown, XXXL, Extra Long

OPERATING ROOM INNOVATIONS, INC.

Surgical gown, single-use

• Primary Device ID: 00854150007255
• NIH Device Record Key: 6014bbe4-0cc2-4a0f-b4a3-a095166cb95b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoloFit
• Version Model Number: SF-4XXXL-EL
• Catalog Number: SF-4XXXL-EL
• Company DUNS: 080246656
• Company Name: OPERATING ROOM INNOVATIONS, INC.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854150007248 [Primary]
GS1	00854150007255 [Package]; Contains: 00854150007248; Package: Case [25 Units]; In Commercial Distribution

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: 2019-10-23
• Device Publish Date: 2019-06-03

Devices Manufactured by OPERATING ROOM INNOVATIONS, INC.

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• 26975424191451 - ORI: 2023-04-12 Face Shield, Attached with Full Head Covering
• 26975424191468 - ORI: 2023-04-12 ORI Drop Stop
• 26975424191475 - ORI: 2023-04-12 Face Shield, Attached w. AAMI IV Head Covering
• 26975085708333 - ORI: 2023-04-11 SmokeStop - Smoke Evacuation 20" Tubing
• 26975085708524 - ORI: 2023-04-11 SterileBack Toga XL-EL w. Face Shield