FDA.report

McKesson

Primary DI
00612479224001
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
4892
Device description
Lite Hydrocellular Foam Dressings SILICONE ADHESIVE | WITHOUT BORDER | GENTLE ADHESIVE | STERILE 3" x 3" Dressing
Published
2018-09-12
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
NADDressing, Wound, Occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479223998PackageGS110In Commercial Distribution
00612479224001PackageGS120In Commercial Distribution
00612479223981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479223998006124792239986124792239980612479223998
00612479224001006124792240016124792240010612479224001
00612479223981006124792239816124792239810612479223981

GMDN Terms

TermDefinition
Wound-nonadherent dressing, absorbent, sterileA sterile wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel) that prevents adherence to the wound bed, thereby decreasing the potential for wound trauma; it does not contain an antimicrobial agent. It is typically used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; 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
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00612479278431McKesson16-618102026-01-26

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