Surgical One D5920-62

GUDID 00850015378508

Leica Microscope Drape for M320/M400, 51x165cm – 20x65"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850015378508
• NIH Device Record Key: 080d3d55-6a51-4c3b-8aa2-c49c4a4a5156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical One
• Version Model Number: D5920-62
• Catalog Number: D5920-62
• 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	00850015378492 [Primary]
GS1	00850015378508 [Package]; Contains: 00850015378492; Package: Inner Case [20 Units]; In Commercial Distribution
GS1	00850015378515 [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: 2020-04-15
• Device Publish Date: 2020-04-07

On-Brand Devices [Surgical One]

• 00850015378508: Leica Microscope Drape for M320/M400, 51x165cm – 20x65"
• 00850015378805: Universal Microscope Head Cover
• 00850024023048: C-Arm Kit with Clips
• 00850024023093: "Mini C-Arm Drape 48""x84"", Fits OEC Mini 6600 & 6800"
• 00850024023062: Microscope Drape- Zeiss MD, 137x381cm - 54"x150"
• 16975424191270: Microscope Handle Cover Drapes 6" x 14", 100/Pair
• 26975085709842: Mini C-Arm Drape 48"x84", Fits OEC Mini 6600 & 6800
• 26975085709835: Mini C-Arm
• 26975085709361: C-Arm Kit with Clips
• 16975424191959: Microscope Drape- Zeiss MD, 137x381cm - 54"x150"
• 26975424191949: Universal Microscope Head Cover
• 16975424191935: Leica Microscope Drape for M320/M400 51x165cm- 20"x65"
• 16975424191805: Microscope Drape, Leica, 137cm x 381cm - 54" x 150"
• 16975424191799: Microscope Drape, Leica, 117cm x 305cm - 46" x 120"
• 06975424191785: Microscope Drape, Leica, 117cm x 203cm - 46" x 80"
• 06975424193369: Handle Drape 13cm x 25cm - 5" x 10", 100/Pair