Medmat 6070D

GUDID 20850003355164

Dual Layer Sterile Procedure Mat - Med Mat 700

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use, sterile Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use Patient surgical drape, single-use

• Primary Device ID: 20850003355164
• NIH Device Record Key: 5365e508-17db-4136-a115-c37f79e2fabb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medmat
• Version Model Number: 6070D
• Catalog Number: 6070D
• 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	00850003355160 [Primary]
GS1	10850003355167 [Package]; Contains: 00850003355160; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	20850003355164 [Package]; Contains: 10850003355167; Package: Case [4 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-16

On-Brand Devices [Medmat]

• 00850003355245: Dual Layer Sterile Stretcher/Trolley Mat - Med Mad 2500
• 00850003355221: Dual Layer Sterile Procedure Bed Mat - Med Mat 3000
• 00850003355191: Dual Layer Sterile Procedure Mat - Med Mat 1100
• 20850003355164: Dual Layer Sterile Procedure Mat - Med Mat 700