Egg Medical EN-SD-001

GUDID 00850024023307

Clear Spot Shield Sterile Drape

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850024023307
• NIH Device Record Key: 1f433606-2818-4121-a3a1-de707816ffce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Egg Medical
• Version Model Number: EN-SD-001
• Catalog Number: EN-SD-001
• 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	00850024023291 [Primary]
GS1	00850024023307 [Package]; Contains: 00850024023291; Package: case [20 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: 2021-01-26
• Device Publish Date: 2021-01-18

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

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• 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