FDA UDI In Commercial Distribution 🇺🇸 United States

Curity

DI: 10884521138124 · Model: 8042AMD · Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2

Basic Information

Brand Name
Curity
Primary DI
10884521138124
Version / Model
8042AMD
Catalog Number
8042AMD
Company Name
Cardinal Health, Inc.
Labeler DUNS
080935429
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2018-06-27
Public Version
3
Public Version Date
2022-11-30
Public Version Status
Update
Public Device Record Key
05f185c3-41d4-459e-ad6f-397a5985161c

Device Description

AMD Antimicrobial Non-woven Sponges,4 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
13701 Germicidal sponge

Identifiers

Type ID
Package 20884521138121
Primary 10884521138124
Package 30884521138128
Unit of Use 40884521138125

Device Sizes

Type Value Unit Text
Width 2 Inch
Length 2 Inch

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
;