Coulmed Products Group DI-5419

GUDID 00850003355771

C-Arm Drape 104x188cm with Elastic Bands

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850003355771
• NIH Device Record Key: dac0fb1d-2caa-436c-a099-2e1bbc0dc384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coulmed Products Group
• Version Model Number: DI-5419
• Catalog Number: DI-5419
• 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	00850003355764 [Primary]
GS1	00850003355771 [Package]; Contains: 00850003355764; Package: Case [20 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-10-30

On-Brand Devices [Coulmed Products Group]

• 00850003355870: 3/4 Drape Sheet 57"x63"
• 00850003355856: C-Arm Kit XI, C1 Clip Drape 86", 2 Band 36"x36", FSC
• 00850003355832: Mayo Stand Cover 23"x54"
• 00850003355818: Cassette Cover 61x61cm - 24"x24"
• 00850003355788: Camera Drape, Blue Elasticized Tip 18x244cm
• 00850003355771: C-Arm Drape 104x188cm with Elastic Bands
• 00850003355757: Mini C-Arm Drape, Fits OEC Mini 6800
• 00850003355733: Double Back Table Cover - 5' wide with 8" Back
• 00850003355719: Double Back Table Cover - 6' wide with 8" Back
• 00850003355696: Double Back Table Cover - 5' wide
• 00850015378003: Double Back Table Cover - 4' wide
• 00850024023956: Double Back Table Cover - 4' wide
• 00850024023970: Double Back Table Cover - 5' wide with 8" Back
• 00850024023994: Double Back Table Cover - 6' wide with 8" Back
• 00850024023963: Double Back Table Cover - 5' wide
• 26975085709866: Double Back Table Cover 6'
• 26975085709859: Double Back Table Cover 5'