FDA.reportPublic FDA data

PHONAK

Primary DI
EGOL840851
Brand
PHONAK
Company
Egger Otoplastik + Labortechnik GmbH
Model
C&C Wipe
Published
2023-01-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EGOL840851PrimaryHIBCC0
EGOL840940Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning/disinfection wipeA moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.

Regulatory Flags#

DUNS number
328465042
Device count
25
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EGOL206041eggerA/ITE2022-08-31
EGOL206171eggerA/soft S 502022-08-31
EGOL840940PHONAKC&C Wipe2023-01-01
EGOL206001eggerA/soft2022-08-31
EGOL207001eggerflex/AB 40 shore, reddish-transparent2022-08-31
EGOL207021eggerflex/AB 40 shore, beige2022-08-31
EGOL207031eggerflex/AB 40 shore, red2022-08-31
EGOL207041eggerflex/AB 40 shore, blue2022-08-31
EGOL207071eggerflex/AB 40 shore, white2022-08-31
EGOL207081eggerflex/AB 40 shore, green2022-08-31
EGOL207091eggerflex/AB 40 shore, yellow2022-08-31
EGOL207161eggerflex/AB 40 shore, black2022-08-31
EGOL207181eggerflex/AB 40 shore, transparent2022-08-31
EGOL207191eggerflex/AB 40 shore, orange2022-08-31
EGOL207351eggerflex/AB 25 shore, transparent2022-08-31
EGOL208101eggerflex/AB 40 shore, reddish-transparent2022-08-31
EGOL208181eggerflex/AB 40 shore, transparent2022-08-31
EGOL208351eggerflex/AB 40 shore, pink2022-08-31
EGOL208361eggerflex/AB 40 shore, purple2022-08-31
EGOL208401eggerflex/AB 60 shore, S 50, colorless-transparent2022-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884392008420Safety 1stDOREL JUVENILE GROUP, INC.LRJ2025-12-15
10197344169085MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
20197344169082MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
00850080488072flysoundShenzhen Flysounds Medical Technology Co.,Ltd.LRJ2025-11-14
H816PSC050Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantMicroCare, LLCLRJ2025-10-23
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00615375013458CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00615375013472CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013455CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013479CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00815027010303DALTON WET WIPEDALTON MEDICAL CORPORATIONLRJ2025-05-15
00025469093455Ecolab Bleach Disinfectant WipeEcolab Inc.LRJ2025-05-09
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06976301910796YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
10197344017683MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
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