Exact Medical Manufacturing, Inc. CS1002

GUDID 16975424196183

Robotic assistant surgical cover

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment/instrument drape, single-use

• Primary Device ID: 16975424196183
• NIH Device Record Key: 9e7b0409-de6f-46b5-bbe3-49cbd670c9df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Medical Manufacturing, Inc.
• Version Model Number: CS1002
• Catalog Number: CS1002
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424196186 [Primary]
GS1	16975424196183 [Package]; Contains: 06975424196186; Package: Inner Case [25 Units]; In Commercial Distribution
GS1	26975424196180 [Package]; Package: Case [1 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: 2024-11-11
• Device Publish Date: 2024-11-01

On-Brand Devices [Exact Medical Manufacturing, Inc.]

• 06975085709183: Cover IID 168x60cm
• 16975424196183: Robotic assistant surgical cover
• 26975424196166: Sterile Cover with perforated tip 5" x 96"
• 16975424196480: C-Arm B Model Ziehm VI (6)
• 16975424196459: Cover IID 168x60cm