Customed 9004820

GUDID 00850003355085

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850003355085
• NIH Device Record Key: c9ef3ebe-896a-4b85-8c13-8273f73ab3e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Customed
• Version Model Number: 9004820
• Catalog Number: 9004820
• 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	00850003355085 [Primary]

FDA Product Code

• KKX: Drape, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-01-09

On-Brand Devices [Customed]

• 10850003355150: Probe Cover, PE, Gel and Elastic bands 15x244cm - 6"x96"
• 10850003355143: C-Arm Drape 104x188cm - 41"x74"
• 10850003355136: C-Arm Drape 104x163cm - 41"x64"
• 10850003355129: Probe Cover, PE, Elastic bands 15x244cm - 6"x96"
• 10850003355112: Camera Drape, Blue Elastic Tip, 23x244cm - 9"x96"
• 00850003355108: Microscope Drape, Zeiss MD, 137x381cm - 54"x150"
• 00850003355085: 9004820
• 10850003355075: Band Bag with tape 102x102cm - 40"x40"
• 00850003355061: Microscope Drape, Leica, 104x267cm - 41x105"
• 00850003355986: Probe Cover, PE, Gel and Elastic bands 15x244cm, 6"x96"
• 00850015378218: Microscope Drape- Leica 137x305cm - 54"x120"