FDA.reportPublic FDA data

Schneider

Primary DI
00198737023536
Brand
Schneider
Company
Avatech Corp.
Model
VF3044RP
Device description
Schneider VitaFoam™ Bordered Silicone Foam Adhesive Dressing 4" x 4", 5 Count Per Box
Published
2025-04-18
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198737023536PackageGS190In Commercial Distribution
00198737023529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198737023536001987370235361987370235360198737023536
00198737023529001987370235291987370235290198737023529

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Width4Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool, dry place. Avoid excessive heat and direct sun light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 598-7755support@schneidercare.com

Regulatory Flags#

DUNS number
073477685
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
true
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
00810112473667SwiftGripEN35WC02026-01-23
00810112473674SwiftGripEN35WC12026-01-23
00810112473698SwiftGripEN35WC32026-01-23
00810112473704SwiftGripEN35WC42026-01-23
00810112473711SwiftGripEN35WC52026-01-23
00810112473780SwiftGripEN35WD02026-01-23
00810112473803SwiftGripEN35WD22026-01-23
00810112473810SwiftGripEN35WD32026-01-23
00810112473827SwiftGripEN35WD42026-01-23
00810112473834SwiftGripEN35WD52026-01-23
00810112473728SwiftGripEN35WC02026-01-23
00810112473735SwiftGripEN35WC12026-01-23
00810112473759SwiftGripEN35WC32026-01-23
00810112473766SwiftGripEN35WC42026-01-23
00810112473773SwiftGripEN35WC52026-01-23
00810112473841SwiftGripEN35WD02026-01-23
00810112473797SwiftGripEN35WD12026-01-23
00810112473865SwiftGripEN35WD22026-01-23
00810112473872SwiftGripEN35WD32026-01-23
00810112473889SwiftGripEN35WD42026-01-23

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