FDA.reportPublic FDA data

American White Cross

Primary DI
30665973018073
Brand
American White Cross
Company
Dukal LLC
Model
17576
Catalog number
17576
Device description
Eye Pad 1-5/8" x 2-5/8", Sterile
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
30665973018073PackageGS124In Commercial Distribution
10665973018079PrimaryGS10
00665973018072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3066597301807330665973018073
1066597301807910665973018079
00665973018072006659730180726659730180720665973018072

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
791014871
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12
20665973033024Dukal553055302026-02-26
20665973020918Dukal11130111302026-01-30
20665973020932Dukal11127111272026-01-30
30665973032611Dukal986098602025-10-31
30665973032628Dukal986198612025-10-31
30665973032598DukalK-10040K-100402025-09-18
30665973032451UnipackUPP-1015UPP-10152025-06-01
30665973032475UnipackUPP-223UPP-2232025-06-01
30665973032482UnipackUPP-225UPP-2252025-06-01
30665973032499UnipackUPP-29UPP-292025-06-01
30665973032505UnipackUPP-3212UPP-32122025-06-01
30665973032512UnipackUPP-3565UPP-35652025-06-01
30665973032529UnipackUPP-4212UPP-42122025-06-01
30665973032536UnipackUPP-5211UPP-52112025-06-01
30665973032543UnipackUPP-5275UPP-52752025-06-01
30665973032550UnipackUPP-7513UPP-75132025-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06950396345435Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-01-28
06950396345459Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-01-28
00810124532109Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00653160388701MEDLINEMEDLINE INDUSTRIES, INC.HMP2025-07-14
08681756010028PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756012916PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08682952413262PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
00690521023932Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
00690521023949Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
00690521025165Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
16974567748075RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
16974567748082RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
00840117334755Eyepad - 18"x 36" DYNAREX CORPORATIONHMP2024-03-25
00810077219898Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
06975374678015MasterDongguan Maisite Medical Instruments Co., Ltd.HMP2023-05-12
06950396300014ChaoyaHenan Chaoya Medical Equipment Co., Ltd.HMP2023-04-24
86974567748074RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2023-03-03
86974567748081RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2023-03-03
96974567748071RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2023-03-03
96974567748088RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2023-03-03
06974567748085RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2023-03-03
06974567748078RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2023-03-03
04042809687477Leukoplast®BSN medical GmbHHMP2022-12-08
04042809687521Leukoplast®BSN medical GmbHHMP2022-12-08
20665973014900DukalDukal LLCHMP2022-12-06
06974567745299EMSRUNWuxi Emsrun Technology Co., Ltd.HMP2022-12-02
30665973018097American White CrossDukal LLCHMP2022-12-02
0076658806123824PW - Turtle Top Florida DOT - Poly WhiteCertified Safety Manufacturing, Inc.HMP2022-07-15