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.

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• 26975424198283 - Exact Medical Manufacturing, Inc.: 2025-12-11 Urological Drain Bag - GE/OEC 2000, Liebel Table,8mm Adaptor
• 26975424198306 - Exact Medical Manufacturing, Inc.: 2025-12-11 Urological Drain Bag - Skytron Table, 8mm Adaptor
• 26975424198320 - Exact Medical Manufacturing, Inc.: 2025-12-11 Urological Drain Bag - Siemens Table, 8mm Adaptor
• 26975424198344 - Exact Medical Manufacturing, Inc.: 2025-12-11 Uro-Catcher Bag - Fits All Hoop Style Frames, 8mm Adaptor
• 26975424198368 - Exact Medical Manufacturing, Inc.: 2025-12-11 Uro-Catcher Bag - Fits All Hoop Style Frames, 6mm Adaptor
• 26975424198382 - Exact Medical Manufacturing, Inc.: 2025-12-11 Urological Drain Bag - GE/OEC UroView 2600/2800 w/ Covers
• 26975424198535 - Exact Medical Manufacturing, Inc.: 2025-12-04 Leica Microscope Drape 46” x 80”, Bayonet with Drawcord