Infab Corp

GUDID 00850031271746

C-Arm Drape-Mini 137x160cm - 54"x63"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850031271746
• NIH Device Record Key: ed32ff5d-cbf4-4e42-b0f2-76e89b9b8a7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infab Corp
• Version Model Number: 4003
• 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	00850031271722 [Primary]
GS1	00850031271746 [Package]; Contains: 00850031271722; Package: Inner Case [20 Units]; In Commercial Distribution
GS1	00850031271753 [Package]; Package: Case [2 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: 2021-06-28
• Device Publish Date: 2021-06-18

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

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• 16975424195568 - OSIS Medical: 2024-07-04 OSIS DRAPE - LEICA MICROSCOPE - MEDIUM - 46"X120"
• 16975424195575 - OSIS Medical: 2024-07-04 OSIS DRAPE - LEICA MICROSCOPE - MINI - 46"X80"
• 16975424192895 - Exact Medical Manufacturing: 2024-06-17 Keyboard Cover 30x10cm