ORI SF-4L-EL

GUDID 10850003355914

SoloFit AAMI IV SMS Gown L, Extra Long

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use

• Primary Device ID: 10850003355914
• NIH Device Record Key: 2b486d76-d4df-41dc-9f8d-f1db7c532465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORI
• Version Model Number: SF-4L-EL
• Catalog Number: SF-4L-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	00850003355917 [Primary]
GS1	10850003355914 [Package]; Contains: 00850003355917; 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: 2019-12-10
• Device Publish Date: 2019-12-02

On-Brand Devices [ORI]

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• 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