Exact Memdical Manufacturing EP54-120

GUDID 20852205007964

Microscope Drape-Leica, Bayonet, 137x305cm - 54"x120"

EXACT MEDICAL MANUFACTURING, INC.

Instrument/equipment drape, single-use, sterile

• Primary Device ID: 20852205007964
• NIH Device Record Key: 9c622bb2-1d13-4ffe-a636-b8e963fa4b0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Memdical Manufacturing
• Version Model Number: EP54-120
• Catalog Number: EP54-120
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 716-681-0866
• Email: rdean@exactmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852205007960 [Primary]
GS1	10852205007967 [Package]; Contains: 00852205007960; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	20852205007964 [Package]; Contains: 10852205007967; Package: Outer 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: 2018-10-08
• Device Publish Date: 2018-09-06

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

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• 16975424195551 - OSIS Medical: 2024-07-04 OSIS DRAPE - LEICA MICROSCOPE - LARGE - 54"X150"
• 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