FDA.report

Coverlet®

Primary DI
10035664013070
Brand
Coverlet®
Company
BSN MEDICAL, INC.
Model
78015-00
Catalog number
78015-00
Device description
COVERLET ELASTIC 2" X 2 1/2" LARGE TAN 50 DIGIT
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
true
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
10035664013070PackageGS112In Commercial Distribution
00035664013073PrimaryGS10
00035664030650Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1003566401307010035664013070
00035664013073000356640130730356640130730035664013073
00035664030650000356640306500356640306500035664030650

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
Device Size Text, specify0
Length6.35Centimeter
Width5Centimeter

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
026301221
Device count
50
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
false
No natural rubber latex
true
Sterilization required before use
false

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04042809841749JOBST forMen60520-1160520-112025-07-01
04042809841756JOBST forMen60532-0060532-002025-07-01
04042809841763JOBST forMen60532-0160532-012025-07-01

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