FDA.reportPublic FDA data

Coverlet®

Primary DI
00035664030728
Brand
Coverlet®
Company
BSN MEDICAL, INC.
Model
78022-00
Catalog number
78022-00
Device description
COVERLET ELASTIC 21/8"X1.5" TAN SMALL DIGIT BULK
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

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
10035664026612PrimaryGS10
00035664030728Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003566402661210035664026612
00035664030728000356640307280356640307280035664030728

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
Length3.8Centimeter
Width1.9Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
026301221
Device count
4875
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042809649796ZONAS® by Actimove®65001-0465001-042025-09-02
04042809818581ZONAS® by Actimove®65001-0165001-012025-09-02
04042809662764JOBST forMen60520-0060520-002025-07-01
04042809663143JOBST forMen60520-0160520-012025-07-01
04042809687828JOBST forMen60520-2060520-202025-07-01
04042809702033JOBST forMen60422-0360422-032025-07-01
04042809702040JOBST forMen60422-0560422-052025-07-01
04042809702057JOBST forMen60422-0660422-062025-07-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479282179McKessonMCKESSON MEDICAL-SURGICAL INC.NAD2026-03-17
06974795053920MEDLOTHenan Maidingkang Medical Technology Co., Ltd.NAD2026-03-13
30885632495469HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495851HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495868HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495875HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495882HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496742HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496766HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
06974843740574MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740581MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740598MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740604MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740741MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740758MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740765MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740772MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740789MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740796MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740802MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740819MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740826MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740833MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740840MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740857MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740864MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740871MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740888MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740895MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740901MemGardDalian Orientech Co.,LtdNAD2026-03-10