FDA.reportPublic FDA data

McKesson

Primary DI
00612479127340
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-4812
Device description
Adhesive Bandages FABRIC | SPOT STERILE 1 in.
Published
2019-04-23
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

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479127340PackageGS124In Commercial Distribution
00612479127333PrimaryGS10
00612479127326Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479127340006124791273406124791273400612479127340
00612479127333006124791273336124791273330612479127333
00612479127326006124791273266124791273260612479127326

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
100
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00819143026354HealquHealqu LLCKGX2026-03-05
00819143026453HealquHealqu LLCKGX2026-03-05
00861092002644Cealogic FilmRECIBIO, INC.KGX2026-03-01
50192253049815TelfaCardinal Health 200, LLCKGX2026-02-25
50192253050088TelfaCardinal Health 200, LLCKGX2026-02-25
30197344181654CURADMEDLINE INDUSTRIES, INC.KGX2026-02-23
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05715205000360Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000407Plum QuickFixPlum Safety ApSKGX2026-02-17
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05715205000469Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205100015Plum QuickSoftPlum Safety ApSKGX2026-02-17
05715205110014Plum QuickSoftPlum Safety ApSKGX2026-02-17
05715205120013Plum QuickSoftPlum Safety ApSKGX2026-02-17
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00197998028090Solventum™ Micropore™Solventum US LLCKGX2026-02-15
00197998028410Solventum™ Micropore™Solventum US LLCKGX2026-02-15