Prescott DE5513G

GUDID 16975085709296

Microscope Drape, Leica, Bayonet, 137x381cm -54"x150"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 16975085709296
• NIH Device Record Key: 93b4418d-3610-4b47-a1af-1701ae2d477f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prescott
• Version Model Number: DE5513G
• Catalog Number: DE5513G
• 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	06975085709299 [Primary]
GS1	16975085709296 [Package]; Contains: 06975085709299; Package: Case [10 Units]; In Commercial Distribution
GS1	26975085709293 [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: 2023-04-12
• Device Publish Date: 2023-04-04

On-Brand Devices [Prescott]

• 00850024023161: Microscope Drape- Zeiss MD 112x320cm - 44"x126"
• 00850024023277: Microscope Drape - Zeiss Opmi 51x165cm- 20" x 65"
• 00850024023246: Microscope Drape - Zeiss MD 117x381cm - 46" x 150"
• 00850024023352: Microscope Drape- Zeiss MD 104x229cm - 41"x90"
• 16975085709333: Microscope Drape- Zeiss Opmi 51x165cm- 20"x65"
• 16975085709326: Microscope Drape- Zeiss MD 104x229cm - 41"x90"
• 16975085709319: Microscope Drape- Zeiss MD 117x381cm - 46"x150"
• 16975085709302: Microscope Drape- Zeiss MD 112x320cm - 44"x126"
• 16975085709296: Microscope Drape, Leica, Bayonet, 137x381cm -54"x150"