FDA.reportPublic FDA data

Coverlet®

Primary DI
04042809244113
Brand
Coverlet®
Company
BSN MEDICAL, INC.
Model
46430-00
Catalog number
46430-00
Device description
COVERLET EYE OCCLUSOR 50X76MM REGULAR BEIGE 20 USA
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
04042809244120PackageGS12In Commercial Distribution
04042809709513PackageGS16In Commercial Distribution
04042809244113PrimaryGS10
04042809624410Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809244120040428092441204042809244120
04042809709513040428097095134042809709513
04042809244113040428092441134042809244113
04042809624410040428096244104042809624410

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.7Centimeter
Width5Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)537-1063HMS.ORDERS@ESSITY.COM

Regulatory Flags#

DUNS number
026301221
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00035664600266JOBST Custom Seamed75074-0075074-002026-05-11
00035664600273JOBST Custom Seamed75074-0175074-012026-05-11
00035664600860JOBST Custom Seamed75065-0075065-002026-05-11
00035664600891JOBST Custom Seamed75066-0075066-002026-05-11
00035664601089JOBST Custom Seamed75067-0075067-002026-05-11
00035664601348JOBST Custom Seamed75064-0075064-002026-05-11
00035664601355JOBST Custom Seamed75064-0175064-012026-05-11
00035664601423JOBST Custom Seamed75071-0075071-002026-05-11
00035664601430JOBST Custom Seamed75071-0175071-012026-05-11
00035664601447JOBST Custom Seamed75071-0275071-022026-05-11
00035664601454JOBST Custom Seamed75072-0075072-002026-05-11
00035664601461JOBST Custom Seamed75071-0675071-062026-05-11
00035664601478JOBST Custom Seamed75071-0775071-072026-05-11
00035664601508JOBST Custom Seamed75071-0375071-032026-05-11
00035664601515JOBST Custom Seamed75071-0475071-042026-05-11
00035664601522JOBST Custom Seamed75071-0575071-052026-05-11
04042809633061JOBST Sport752896175289612018-06-30
04042809633146JOBST Sport752906175290612018-06-30
04042809649277ZONAS® by Actimove®65001-0465001-042025-09-02
04042809818574ZONAS® by Actimove®65001-0165001-012025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206823977kegel Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827081Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827098Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827104Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828149Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828156Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828163Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828170Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
10885632506000HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506017HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506024HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29