FDA.reportPublic FDA data

NTERFACE

Primary DI
00858150000490
Brand
NTERFACE
Company
WINFIELD LABORATORIES INC
Model
3810-288
Catalog number
3810-288
Device description
Large Sheet 12 inches X 24 inches - Box 12
Published
2020-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10858150000497PackageGS148In Commercial Distribution
00858150000490PrimaryGS10
00858150000520Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085815000049710858150000497
00858150000490008581500004908581500004900858150000490
00858150000520008581500005208581500005200858150000520

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

Contacts#

Phone, Email table
PhoneEmail
801-352-0600chrisd@winfieldlabs.com

Regulatory Flags#

DUNS number
050087089
Device count
12
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858150000476NTERFACE4480-124480-122020-07-14
00858150000483NTERFACE3810-1443810-1442020-07-14
00858150000506NTERFACE4120-48RL4120-48RL2020-07-14
00858150000469NTERFACE4480-044480-042020-07-14
00858150000537NTERFACE4480-124480-122020-07-14
00858150000544NTERFACE3810-1443810-1442020-07-14
00858150000520NTERFACE3810-2883810-2882020-07-14
00858150000551NTERFACE4120-48RL4120-48RL2020-07-14

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