FDA.report

LEADER

Primary DI
50096295124014
Brand
LEADER
Company
CARDINAL HEALTH, INC.
Model
4902391
Catalog number
4902391
Device description
Antibacterial Clear Bandages; Active Ingredient Benzalkonium Chloride 0.1 Percent; All One Size 3/4 IN. x 3 IN.
Published
2019-04-18
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

Related Records

Contact Domains

Product Codes

CodeName
KGXTape and bandage, adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50096295124014PackageGS124In Commercial Distribution
00096295124019PrimaryGS10
10096295124016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5009629512401450096295124014
00096295124019000962951240190962951240190096295124019
1009629512401610096295124016

GMDN Terms

TermDefinition
Skin-cover adhesive strip, antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)200-6313xxx@xxx.xxx

Regulatory Flags

DUNS number
097537435
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true
Sterilization required before use
false

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