FDA.report

Coverlet®

Primary DI
04042809709506
Brand
Coverlet®
Company
BSN MEDICAL, INC.
Model
46429-00
Catalog number
46429-00
Device description
COVERLET EYE OCCLUSOR 48X63MM JUNIOR 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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NADDressing, wound, occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04042809244106PackageGS12In Commercial Distribution
04042809709506PackageGS16In Commercial Distribution
04042809244090PrimaryGS10
04042809663723Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042809244106040428092441064042809244106
04042809709506040428097095064042809709506
04042809244090040428092440904042809244090
04042809663723040428096637234042809663723

GMDN Terms

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

TypeValueUnit
Length6.3Centimeter
Width4.8Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)537-1063HMS.ORDERS@ESSITY.COM

Regulatory Flags

DUNS number
026301221
Device count
20
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
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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04042809841657JOBST forMen60520-0260520-022025-07-01
04042809841664JOBST forMen60520-0360520-032025-07-01
04042809841671JOBST forMen60520-0460520-042025-07-01
04042809841688JOBST forMen60520-0560520-052025-07-01
04042809841695JOBST forMen60520-0660520-062025-07-01
04042809841701JOBST forMen60520-0760520-072025-07-01
04042809841718JOBST forMen60520-0860520-082025-07-01
04042809841725JOBST forMen60520-0960520-092025-07-01
04042809841732JOBST forMen60520-1060520-102025-07-01
04042809841749JOBST forMen60520-1160520-112025-07-01
04042809841756JOBST forMen60532-0060532-002025-07-01
04042809841763JOBST forMen60532-0160532-012025-07-01

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