Flex Operating Room, LLC

GUDID 26975424194407

Triple Wide Orange Cover

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 26975424194407
• NIH Device Record Key: 2b04ce72-f564-4b97-9062-d8d0d40528b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex Operating Room, LLC
• Version Model Number: 111-3222
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424194403 [Primary]
GS1	26975424194407 [Package]; Contains: 06975424194403; Package: Case [10 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: 2023-10-04
• Device Publish Date: 2023-09-26

On-Brand Devices [Flex Operating Room, LLC]

• 26975424194407: Triple Wide Orange Cover
• 26975424194391: Double Wide Orange Cover