FDA.report

McKesson

Primary DI
40612479198539
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
61-20056
Device description
Dressing Petrolatum 3"x9"
Published
2020-06-09
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

Related Records

Product Codes

CodeName
FERAnoscope And Accessories
GERGauze, External (With Drug/Biologic/Animal Source Material)

Product Code Classifications

CodeDeviceSpecialtyClass
FERAnoscope And AccessoriesGastroenterology, Urology2
GERGauze, External (With Drug/Biologic/Animal Source Material)

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40612479198539PackageGS16In Commercial Distribution
20612479198528PrimaryGS10
10612479198514Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4061247919853940612479198539
2061247919852820612479198528
1061247919851410612479198514

GMDN Terms

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

Regulatory Flags

DUNS number
023904428
Device count
12
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

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20612479282906McKessonM-1667H2026-05-26
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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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