FDA.reportPublic FDA data

American White Cross

Primary DI
10665973018093
Brand
American White Cross
Company
Dukal LLC
Model
17570 and 17571
Catalog number
17570 and 17571
Device description
"Eye Pad 2-1/8"" x 2-5/8"", Sterile"
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMPPAD, EYE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMPPad, EyeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20665973018090PackageGS150In Commercial Distribution
30665973018097PackageGS124In Commercial Distribution
40665973018094PackageGS1500In Commercial Distribution
10665973018093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2066597301809020665973018090
3066597301809730665973018097
4066597301809440665973018094
1066597301809310665973018093

GMDN Terms#

Term, Definition table
TermDefinition
Eye padA cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973029488UnipackUGC-6600-LUGC-6600-L2022-12-06
10665973029495UnipackUGC-6600-MUGC-6600-M2022-12-06
10665973029501UnipackUGC-6600-SUGC-6600-S2022-12-06
10665973029518UnipackUGC-6600-XLUGC-6600-XL2022-12-06
10665973029525UnipackUGC-6600-XXLUGC-6600-XXL2022-12-06
10665973029532UnipackUGC-6601-LUGC-6601-L2022-12-06
10665973029549UnipackUGC-6601-MUGC-6601-M2022-12-06
10665973029556UnipackUGC-6601-SUGC-6601-S2022-12-06
10665973029563UnipackUGC-6601-XLUGC-6601-XL2022-12-06
10665973029570UnipackUGC-6601-XXLUGC-6601-XXL2022-12-06
10665973029587UnipackUGC-6602-LUGC-6602-L2022-12-06
10665973029594UnipackUGC-6602-MUGC-6602-M2022-12-06
10665973029600UnipackUGC-6602-SUGC-6602-S2022-12-06
10665973029617UnipackUGC-6602-XLUGC-6602-XL2022-12-06
10665973029624UnipackUGC-6602-XXLUGC-6602-XXL2022-12-06
10665973029631UnipackUGC-6603-LUGC-6603-L2022-12-06
10665973029648UnipackUGC-6603-MUGC-6603-M2022-12-06
10665973029655UnipackUGC-6603-SUGC-6603-S2022-12-06
10665973029662UnipackUGC-6603-XLUGC-6603-XL2022-12-06
10665973029679UnipackUGC-6603-XXLUGC-6603-XXL2022-12-06

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Primary DI, Brand, Company table
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08681756012916PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08682952413262PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
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06974567748085RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
06974567748078RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
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