SF-3XL Solofit AAMI III SMS Gown X-Large SF-3XL

GUDID 00085415000705

OPERATING ROOM INNOVATIONS, INC.

Operating room gown, single-use

• Primary Device ID: 00085415000705
• NIH Device Record Key: c8500482-1908-4118-9810-3b94bef999cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SF-3XL Solofit AAMI III SMS Gown X-Large
• Version Model Number: SF-3XL
• Catalog Number: SF-3XL
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085415000705 [Package]; Contains: 00854150007040; Package: Case [34 Units]; In Commercial Distribution
GS1	00854150007040 [Primary]

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: 2018-03-29
• Device Publish Date: 2017-03-02

On-Brand Devices [SF-3XL Solofit AAMI III SMS Gown X-Large]

• 00085415000705: SF-3XL
• 00854150007057: SF-3XL