DEVICE: Curity (10884521021983)
Device Identifier (DI) Information
Curity
2533
In Commercial Distribution
2533
Cardinal Health, Inc.
2533
In Commercial Distribution
2533
Cardinal Health, Inc.
AMD Antimicrobial Gauze Sponges,12 Ply USP Type VII, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46854 | Wound-nonadherent dressing, absorbent, non-antimicrobial |
A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EFQ | GAUZE/SPONGE, INTERNAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: This side up; |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 4 Inch |
Width: 4 Inch |
Device Record Status
f0d125b0-99f5-47d9-acae-0c9f9d789da2
September 08, 2023
5
June 29, 2018
September 08, 2023
5
June 29, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00884521022006 | 1200 | 10884521021983 | 2025-12-31 | In Commercial Distribution | CASE |
00884521021993 | 50 | 10884521021983 | 2025-12-31 | In Commercial Distribution | PACK_OR_INNER_PACK |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10884521022003
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined