ACU-GUARD

GUDID 00814105020869

Acu-Guard II easy fit disposable clear sheaths non-sterile

ACUDERM, INC.

Medical equipment drape, single-use, non-sterile

• Primary Device ID: 00814105020869
• NIH Device Record Key: a2783d10-9179-414c-9a0a-b7101c1c0f2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACU-GUARD
• Version Model Number: 0ADG52
• Company DUNS: 071426803
• Company Name: ACUDERM, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 954-733-6935
• Email: cust-service@acuderm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814105020869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915000

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-13
• Device Publish Date: 2020-01-03

On-Brand Devices [ACU-GUARD]

• 10814105020873: Acu-Guard II easy fit disposable clear sheaths sterile packaged 50/box
• 10814105020866: Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box
• 10814105020859: Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box
• 00814105020876: Acu-Guard II easy fit disposable clear sheaths sterile
• 00814105020869: Acu-Guard II easy fit disposable clear sheaths non-sterile
• 00814105020852: Acu-Guard II easy fit disposable clear sheaths non-sterile