FDA.report

HCS

Primary DI
10810132040792
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
HCS0207
Device description
2.5" x 3", Alcohol Prep Pad, Large, 2 Ply, Sterile
Published
2023-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LKBPad, Alcohol, Device Disinfectant

Product Code Classifications

CodeDeviceSpecialtyClass
LKBPad, Alcohol, Device DisinfectantUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810132040792PackageGS110In Commercial Distribution
00810132040795PrimaryGS10
20810132040799Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204079210810132040792
00810132040795008101320407958101320407950810132040795
2081013204079920810132040799

GMDN Terms

TermDefinition
Skin-cleaning wipe, sterileA sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) 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

Regulatory Flags

DUNS number
080220245
Device count
100
DM exempt
true
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

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