Flex Operating Room, LLC

GUDID 06975424191761

Double Wide A-Rack

FLEX OPERATING ROOM, LLC

Medical equipment drape, single-use

• Primary Device ID: 06975424191761
• NIH Device Record Key: 67ed0d6a-e760-4fd8-aca2-99914a71fc31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex Operating Room, LLC
• Version Model Number: 111-2111
• Company DUNS: 080180725
• Company Name: FLEX OPERATING ROOM, LLC
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424191761 [Primary]
GS1	26975424191765 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, 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: 2023-04-07
• Device Publish Date: 2023-03-30

On-Brand Devices [Flex Operating Room, LLC]

• 06975424191778: Triple Wide Rack
• 06975424191761: Double Wide A-Rack