FDA.report

McKesson

Primary DI
00612479193178
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
2207
Device description
Petrolatum Dressing XEROFORM | SHEET 5 in x 9 in
Published
2019-04-09
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

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479193161PackageGS150In Commercial Distribution
00612479193178PackageGS14In Commercial Distribution
00612479193154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479193161006124791931616124791931610612479193161
00612479193178006124791931786124791931780612479193178
00612479193154006124791931546124791931540612479193154

GMDN Terms

TermDefinition
Wound-nonadherent dressing, permeable, antimicrobialA sterile wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin, and that contains an antimicrobial agent (e.g., silver (Ag), honey). Its pores permit the drainage of exudates from, and application of medication to, the wound. This device may be used with other wound-care products to help heal chronic/infected and postoperative wounds, burns, skin grafts, cuts, or abrasions; it is not a dedicated burn dressing. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
1
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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