Bausch Lomb

GUDID 16975424192475

SeeLuma Binoculars Drape

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 16975424192475
• NIH Device Record Key: 4fe05413-2714-44db-96ac-49c1f2289d38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bausch Lomb
• Version Model Number: V10108-01
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424192478 [Primary]
GS1	16975424192475 [Package]; Contains: 06975424192478; Package: Inner Case [30 Units]; In Commercial Distribution
GS1	26975424192472 [Package]; Package: Case [5 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: 2023-05-29
• Device Publish Date: 2023-05-19

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

• 26975424196166 - Exact Medical Manufacturing, Inc.: 2024-11-11 Sterile Cover with perforated tip 5" x 96"
• 16975424196183 - Exact Medical Manufacturing, Inc.: 2024-11-11 Robotic assistant surgical cover
• 00850015378331 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x80cm with tape closure
• 00850015378355 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 12x100cm with tape closure
• 00850015378386 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x120cm with tape closure
• 00850015378416 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x100cm with tape closure
• 00850015378447 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 20x110cm with tape closure
• 00850015378478 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x90cm with tape closure