FDA UDI In Commercial Distribution 🇺🇸 United States

Excilon

DI: 10884521135338 · Model: 7084AMD · Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2

Basic Information

Brand Name
Excilon
Primary DI
10884521135338
Version / Model
7084AMD
Catalog Number
7084AMD
Company Name
Cardinal Health, Inc.
Labeler DUNS
080935429
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2018-06-30
Public Version
4
Public Version Date
2022-12-20
Public Version Status
Update
Public Device Record Key
6ca066c2-bd96-4fe0-9e10-ed6bfcde1f0f

Device Description

AMD Antimicrobial Non-woven Sponges,6 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
EFQ GAUZE/SPONGE, INTERNAL

GMDN Terms

Code Name
48129 Gauze strip, antimicrobial

Identifiers

Type ID
Package 30884521135332
Primary 10884521135338
Package 20884521135335
Unit of Use 40884521135339

Device Sizes

Type Value Unit Text
Width 4 Inch
Length 4 Inch

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
This side up;