FDA.reportPublic FDA data

CSD

Primary DI
00000000001908
Brand
CSD
Company
CHINA SURGICAL DRESSINGS CENTER CO., LTD.
Model
12*12cm
Device description
Alcohol Wipes 50pcs per Box
Published
2020-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical
LKBPad, Alcohol, Device Disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2
LKBPad, Alcohol, Device DisinfectantUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050689000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050689000SURGICAL FACE MASKChina Surgical Dressings Center Co., Ltd.2005-10-26FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04711908601911PrimaryGS10
04711908990367PrimaryGS10
04711908990381PrimaryGS10
04711908990398PrimaryGS10
04711908990404PrimaryGS10
04711908990442PrimaryGS10
04711908990459PrimaryGS10
04711908990466PrimaryGS10
04711908990510PrimaryGS10
04711908990527PrimaryGS10
04711908990558PrimaryGS10
04711908990565PrimaryGS10
00000000001908Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
04711908601911047119086019114711908601911
04711908990367047119089903674711908990367
04711908990381047119089903814711908990381
04711908990398047119089903984711908990398
04711908990404047119089904044711908990404
04711908990442047119089904424711908990442
04711908990459047119089904594711908990459
04711908990466047119089904664711908990466
04711908990510047119089905104711908990510
04711908990527047119089905274711908990527
04711908990558047119089905584711908990558
04711908990565047119089905654711908990565
00000000001908000000000019080000000019080000000001908

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cleaning wipe, non-sterileA non-sterile device consisting of an absorbent fabric pre-soaked in a liquid solution [e.g., with a detergent, alcohol, saline, hyaluronic acid (HA), plant extracts] intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656170990
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
true
Expiration date on label
true
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
04711908990381CSDElastic earloop2020-08-11
04711908990398CSDElastic earloop2020-08-11
04711908990404CSDElastic earloop2020-08-11
04711908990442CSDElastic earloop2020-08-11
04711908990459CSDElastic earloop2020-08-11
04711908990466CSDElastic earloop2020-08-11
04711908990558CSDTie on2020-08-13
04711908990565CSDTie on2020-08-13
04711908601911CSD3*3.2cm-2ply2022-11-10
04711908990367CSD12*12cm2020-08-11
04711908990510CSD12*12cm2020-08-11
04711908990527CSD12*12cm2020-08-11
04711908601737CSD3*3.2cm-2ply2022-11-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10192253045741WebcolCardinal Health 200, LLCLKB2025-09-29
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10192253047073WebcolCardinal Health 200, LLCLKB2025-07-28
10192253047066WebcolCardinal Health 200, LLCLKB2025-06-10
10192253046205WebcolCardinal Health 200, LLCLKB2024-09-05
10653160373858MEDLINEMEDLINE INDUSTRIES, INC.LKB2024-04-25
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169039EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169046CriterionHENRY SCHEIN, INC.FXX2023-07-05
10304040165253CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040165260CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168483CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168490CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168582CriterionHENRY SCHEIN, INC.FXX2023-06-26