DEVICE: American White Cross (10665973018130)

Device Identifier (DI) Information

American White Cross
7510327 and 7565033 and 7590000
In Commercial Distribution
7510327 and 7565033 and 7590000
Dukal LLC
10665973018130
GS1

1
791014871 *Terms of Use
Non Adherent Pad 2" x 3", Sterile
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NAB Gauze / sponge,nonresorbable for external use
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

29ee861c-7f40-409a-982d-52aa704d76d9
December 12, 2022
1
December 02, 2022
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30665973018134 36 20665973018137 In Commercial Distribution Case
20665973018137 10 10665973018130 In Commercial Distribution Box
70665973018132 3600 10665973018130 In Commercial Distribution Case
40665973018131 100 10665973018130 In Commercial Distribution Box
50665973018138 12 40665973018131 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(631)656-3800 172
kmckigney@dukal.com
CLOSE