FDA.reportPublic FDA data

Publix

Primary DI
20041415009688
Brand
Publix
Company
U.S. COTTON, LLC
Model
B FMDLS 0130 R02401 PB
Device description
Sterile Cotton Balls (130ct Medium Size)
Published
2020-02-28
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
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20041415009688PackageGS124In Commercial Distribution
00041415009684PrimaryGS10
10048341800016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2004141500968820041415009688
00041415009684000414150096840414150096840041415009684
1004834180001610048341800016

GMDN Terms#

Term, Definition table
TermDefinition
Cotton wool ball, sterileA sterile, non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use to absorb fluids, typically in a surgical setting. It may be radiopaque to make it visible on x-ray, and may have an attached cord to improve traceability in a surgical setting. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store indoors under normal ambient conditions in sealed package

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-242-1227info@publix.com

Regulatory Flags#

DUNS number
932938897
Device count
130
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00048341007029First+AidS SDDLR 0125 R03606 FAB [was S SDDLR 0125 R03606 FS SDDLR 0125 R03606 FAB2020-02-28
00048341007012First+AidB GRDL 0300 R03606 FAB [was B GRDL 0300 R03606 FBBB GRDL 0300 R03606 FAB2020-02-28
00087701406973Good NeighborS BPDLR 0375 R04801 GD2024-07-30
10048341800146Good NeighborS BPDLR 0375 R04801 GD2024-07-30
00087701485718Good NeighborB FMDLS 0130 R02401 GD2020-02-28
00095859105006U.S. CottonB FMDLS 0500 R01201 USB FMDLS 0500 R01201 US2020-02-28
00096295134476LeaderB FMDLS 0130 R02406 LEA2020-02-28
00048341007135First+AidB FMDLS 0130 R02406 FAB [was B FMDLS 0130 R02406 FB FMDLS 0130 R02406 FAB2020-02-28
00048341011842FischerbrandB PLDL 1000 R00201 AC2020-02-28
00095859110000U.S. CottonB PJDL 1000 R00201 USB PJDL 1000 R00201 US2020-02-28
00095859120009U.S. CottonB PMDL 2000 R00201 USB PMDL 2000 R00201 US2021-02-13
00095859110505U.S. CottonB PXDL 0500 R00401 USB PXDL 0500 R00401 US2020-02-28
00041520863904CareOneB FMDLS 0130 R03606 AHL2020-02-28
00036800186101TopCareB FMDLS 0130 R03606 TPC2020-02-28
00095859100063U.S. CottonL GLUS 0001 R02501 USL GLUS 0001 R02501 US2020-02-28
00095859603106U.S. CottonL GLDL 0001 R01201 USL GLDL 0001 R01201 US2020-02-28
00048341011835FischerbrandB PMDL 2000 R00201 FH2021-02-13
00095859100162U.S. CottonL FZUSS 0160 R01201 USL FZUSS 0160 R01201 US2020-02-28
00048341007111First+AidL FZUSS 0040 R02401 FAB [was L FZUSS 0040 R02401 FL FZUSS 0040 R02401 FAB2020-02-28
00041415009684PublixB FMDLS 0130 R02401 PB2020-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850018327982MHMazza Healthcare LLCFRL2026-04-09
16931918102054HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918103969HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918107936HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918100913HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06
10197106935132CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
10810178830135Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830142Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830159Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830166Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830173Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830180Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10653160382928MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-01-15
10193489009460REMEDYMEDLINE INDUSTRIES, INC.FRL2024-10-24
10193489012521MEDLINEMEDLINE INDUSTRIES, INC.FRL2024-10-24
10850049784402SURGYCOSurgyco LLCFRL2023-12-15
10850049784419SURGYCOSurgyco LLCFRL2023-12-15
10810132041843HCSConcordance Healthcare Solutions LLCFRL2023-10-16
10884389108949MedlineMEDLINE INDUSTRIES, INC.FRL2023-10-12
10850054813203Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813241Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813289Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813296Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813302Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813319Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813098Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12
10850054813104Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12