ORI SB-Toga-XL-EL

GUDID 00850015378270

SterileBack Toga XL-EL

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use

• Primary Device ID: 00850015378270
• NIH Device Record Key: 66172702-1cb1-4e66-8565-0c2687e7a6d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORI
• Version Model Number: SB-Toga-XL-EL
• Catalog Number: SB-Toga-XL-EL
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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	00850015378263 [Primary]
GS1	00850015378270 [Package]; Contains: 00850015378263; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120045

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-06
• Device Publish Date: 2020-02-27

On-Brand Devices [ORI]

• 00850003355672: ORI-Specialty Drape Line Direct Anterior Hip
• 00850003355955: Face Shield, Attached with Full Head Covering
• 00850003355931: Shield Guards-Removable Peel Away
• 10850003355914: SoloFit AAMI IV SMS Gown L, Extra Long
• 00850015378270: SterileBack Toga XL-EL
• 00850015378621: Solofit AAMI III SMS Gown Poly Reinforced XXX-Large