NTERFACE

Primary DI
00858150000551
Brand
NTERFACE
Company
WINFIELD LABORATORIES INC
Model
4120-48RL
Catalog number
4120-48RL
Device description
Roll 4 inches X 10 inches - Box 6
Published
2020-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10858150000503PackageGS124In Commercial Distribution
00858150000506PrimaryGS10
00858150000551Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085815000050310858150000503
00858150000506008581500005068581500005060858150000506
00858150000551008581500005518581500005510858150000551

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
6
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00858150000490NTERFACE3810-2883810-2882020-07-14
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

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