FDA.reportPublic FDA data

McKesson

Primary DI
40612479198591
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
61-77041
Device description
Dressing, oil Emulsion 3"x3"
Published
2020-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GERGauze, External (With Drug/Biologic/Animal Source Material)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GERGauze, External (With Drug/Biologic/Animal Source Material)

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921290000INMAN MEDICAL OIL EMULSION DRESSINGInman Medical Corp.1992-11-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479198591PackageGS112In Commercial Distribution
20612479198580PrimaryGS10
10612479198576Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247919859140612479198591
2061247919858020612479198580
1061247919857610612479198576

GMDN Terms#

Term, Definition table
TermDefinition
Petrolatum woven gauze pad, sterileA sterile, non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
50
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
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479198559McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
10612479198514McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
40612479198539McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
40612479198560McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
10612479198576McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
10612479198606McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
40612479198621McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
00888499000929CARDINAL HEALTHCardinal Health 200, LLCGER2019-10-14
00888499000936CARDINAL HEALTHCardinal Health 200, LLCGER2019-10-14
10885380052224CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052231CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052248CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052262CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052279CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052286CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052293CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052309CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052316CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052323CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052330CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052222CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052239CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
20885380052245CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052260CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
20885380052276CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052284CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052291CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052307CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052314CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052321CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29