Clever Medical 91512

GUDID 00862062000301

CLEVER MEDICAL, INC.

Patient surgical drape, single-use, non-sterile

• Primary Device ID: 00862062000301
• NIH Device Record Key: cd116062-f29a-4cd9-958e-390ab288fb37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clever Medical
• Version Model Number: 91512
• Catalog Number: 91512
• Company DUNS: 070939831
• Company Name: CLEVER MEDICAL, 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862062000301 [Primary]
GS1	00862062000318 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

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: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-10