SF-3PXXL Solofit AAMI III SMS Gown Poly Reinforced XX-Large SF-3PXXL

GUDID 00854150007101

OPERATING ROOM INNOVATIONS, INC.

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• Primary Device ID: 00854150007101
• NIH Device Record Key: 80ad179d-503e-49b1-933c-4d0b8d18d105
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SF-3PXXL Solofit AAMI III SMS Gown Poly Reinforced XX-Large
• Version Model Number: SF-3PXXL
• Catalog Number: SF-3PXXL
• 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	00854150007095 [Primary]
GS1	00854150007101 [Package]; Contains: 00854150007095; Package: Case [24 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: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-03-02

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