Interventional systems E2184

GUDID 00850015378898

Device Cover PE w Needle Guide 15G-21G Elastic Band 35x110cm

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use

• Primary Device ID: 00850015378898
• NIH Device Record Key: a8a316ac-20d8-4956-a68a-0bc409704c37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Interventional systems
• Version Model Number: E2184
• Catalog Number: E2184
• 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	00850015378881 [Primary]
GS1	00850015378898 [Package]; Contains: 00850015378881; Package: inner case [50 Units]; In Commercial Distribution
GS1	00850015378904 [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: 2020-07-28
• Device Publish Date: 2020-07-20

On-Brand Devices [Interventional systems]

• 00850015378928: Sterile Drape CCU 25cm wide x 100cm long
• 00850015378898: Device Cover PE w Needle Guide 15G-21G Elastic Band 35x110cm
• 00850015378867: Device Cover PE w Needle Guide 11G-14G Elastic Band 35x110cm