Exact Medical Manufacturing Inc. E5715G

GUDID 00816953024020

Microscope Drape, Zeiss MD,117x381cm - 46"x150"

EXACT MEDICAL MANUFACTURING, INC.

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• Primary Device ID: 00816953024020
• NIH Device Record Key: 09f61d2d-900a-457b-ba30-ce22d921b174
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Medical Manufacturing Inc.
• Version Model Number: E5715G
• Catalog Number: E5715G
• 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	00816953024013 [Primary]
GS1	00816953024020 [Package]; Contains: 00816953024013; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	00850015378973 [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: 2020-09-29
• Device Publish Date: 2020-09-21

On-Brand Devices [Exact Medical Manufacturing Inc.]

• 00850015378188: XXL Poly-reinforced Surgical Gown
• 00850015378164: XL Poly-reinforced Surgical Gown
• 00850015378140: Large Poly-reinforced Surgical Gown
• 00850015378102: XL Fabric Reinforced Surgical Gown
• 00850015378089: Large Fabric Reinforced Surgical Gown
• 00850015378065: XXL AAMI 3 Non-Reinforced Surgical Gowns
• 00850015378041: XL AAMI 3 Non-Reinforced Surgical Gown
• 00850015378027: Large AAMI 3 Non-Reinforced Surgical Gown
• 00816953024020: Microscope Drape, Zeiss MD,117x381cm - 46"x150"