Excilon 7088

GUDID 20884521020181

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

Cardinal Health, Inc.

Wound-nonadherent dressing, absorbent, sterile Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial

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)

Trademark Results [Excilon]

Mark Image Registration \| Serial	Company Trademark Application Date
EXCILON 79105119 4212109 Dead/Cancelled	Shanghai Excilon Chemical Co., Ltd. 2011-09-27
EXCILON 79105100 4192553 Dead/Cancelled	Shanghai Excilon Chemical Co., Ltd. 2011-09-26
EXCILON 77837841 not registered Dead/Abandoned	Shanghai Yousi Polymer Material Scienceand Technology Development Co., Ltd. 2009-09-30
EXCILON 73491090 1336485 Live/Registered	Kendall Company; The 1984-07-23