FDA.reportPublic FDA data

MedVance

Primary DI
00810042270251
Brand
MedVance
Company
MED WAY INC.
Model
V3010412W
Device description
Bordered Silicone Foam dressing with wing 4x12 inches
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810042270251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042270251008100422702518100422702510810042270251

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA 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), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing 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 table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
112481778
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042270084MedVanceV30208202025-09-17
00810042270237MedVanceV3010408W2025-09-17
00810042270558MedVanceV30206082025-09-17
00810042270619MedVanceV3010303-102025-09-17
00810042270626MedVanceV3010202-102025-09-17
00810042270633MedVanceV3010205-102025-09-17
00810042270640MedVanceV3010404-102025-09-17
00810042270657MedVanceV3110707-102025-09-17
00810042270770MedVanceV3010408-102025-09-17
00810042270787MedVanceV3010412-102025-09-17
00810042270794MedVanceV3010606-102025-09-17
00810042271548MedVanceV30106082025-09-17
00857544007015MedVanceV30104042025-09-17
00857544007046MedVanceV30106062025-09-17
00857544007077MedVanceV30102022025-09-17
00857544007107MedVanceV30103032025-09-17
00857544007169MedVanceV31107072025-09-17
00857544007190MedVanceV31109092025-09-17
00857544007497MedVanceV40000122025-09-17
00857544007800MedVanceV30102052025-09-17

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Primary DI, Brand, Company table
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