FDA.reportPublic FDA data

U.S. Cotton

Primary DI
10048341800054
Brand
U.S. Cotton
Company
U.S. COTTON, LLC
Model
B PMDL 2000 R00201 US
Catalog number
B PMDL 2000 R00201 US
Device description
Cotton Balls (2000ct Medium Size)
Published
2021-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10095859120006PackageGS12In Commercial Distribution
00095859120009PrimaryGS10
10048341800054Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1009585912000610095859120006
00095859120009000958591200090958591200090095859120009
1004834180005410048341800054

GMDN Terms#

Term, Definition table
TermDefinition
Cotton wool ball, non-sterileA non-sterile, non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical 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
1-800-321-1029e.sales@uscotton.com

Regulatory Flags#

DUNS number
932938897
Device count
2000
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

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Primary DI, Brand, Company table
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00199536925106BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
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20197344219428MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219442MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
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20197344219466MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219473MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219480MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219497MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219503MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219435MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-13
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
B090MT630MorTanZien Medical Technologies, LLCFRL2026-02-17
00858303003002SynterventionZien Medical Technologies, LLCFRL2025-09-25