Artromed AM3008

GUDID 16975085709425

Camera Drape, Closed System Coupler & Ring Applicator, 6"x98"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 16975085709425
• NIH Device Record Key: f6f07603-9df0-4dea-9837-956d8937bb92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artromed
• Version Model Number: AM3008
• Catalog Number: AM3008
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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	06975085709428 [Primary]
GS1	16975085709425 [Package]; Contains: 06975085709428; Package: Case [32 Units]; In Commercial Distribution
GS1	26975085709422 [Package]; Package: Case [2 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: 2023-04-12
• Device Publish Date: 2023-04-04

On-Brand Devices [Artromed]

• 16975085709111: Camera Drape, Blue Elasticized Tip 18x244cm
• 16975085709104: CAK XI, C1 Clip Drape 86", 2 band 36x36", FSC
• 16975085709425: Camera Drape, Closed System Coupler & Ring Applicator, 6"x98"