Medrobotics 23026

GUDID 10850003355006

Flex Console Cover

EXACT MEDICAL MANUFACTURING, INC.

Instrument/equipment drape, single-use, sterile

• Primary Device ID: 10850003355006
• NIH Device Record Key: 232fb061-0a00-473f-a4a2-43ff85ae82f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medrobotics
• Version Model Number: 23026
• Catalog Number: 23026
• 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	00850003355009 [Primary]
GS1	10850003355006 [Package]; Contains: 00850003355009; Package: Case [10 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: 2018-11-26
• Device Publish Date: 2018-10-24

On-Brand Devices [Medrobotics]

• 00852205007991: Flex Monitor Cover
• 10850003355006: Flex Console Cover