Excilon 7088

GUDID 20884521020181

AMD Antimicrobial Drain Sponges, 6 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)

Cardinal Health, Inc.

Wound-nonadherent dressing, absorbent, sterile

• Primary Device ID: 20884521020181
• NIH Device Record Key: 2ae4d405-bd7d-47da-b8a6-090913cf259d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excilon
• Version Model Number: 7088
• Catalog Number: 7088
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 2
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884521020187 [Primary]
GS1	00884521713515 [Unit of Use]
GS1	10884521020184 [Package]; Contains: 00884521020187; Package: PACK_OR_INNER_PACK [50 Units]; In Commercial Distribution
GS1	20884521020181 [Package]; Contains: 00884521020187; Package: CASE [600 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011941

FDA Product Code

• EFQ: GAUZE/SPONGE, INTERNAL

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: 2019-02-15
• Device Publish Date: 2018-06-28

On-Brand Devices [Excilon]

• 10884521067080: Drain Sponges,6 Ply
• 20884521020181: AMD Antimicrobial Drain Sponges, 6 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
• 30884527023329: I.V. Sponges,6 Ply
• 30884521135332: AMD Antimicrobial Non-woven Sponges,6 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
• 20884521020211: AMD Antimicrobial I.V. Drain Sponges 6 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)