FDA.reportPublic FDA data

EXEL ZORBAND BANDAGE, LARGE

Primary DI
10020221268345
Brand
EXEL ZORBAND BANDAGE, LARGE
Company
Exel International
Model
26834
Catalog number
26834
Device description
EXEL ZORBAND BANDAGE, LARGE 100/BX, 1000/CS, 12CS/CRTN
Published
2023-03-21
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

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10020221268345PackageGS1100In Commercial Distribution
20020221268342PackageGS110In Commercial Distribution
30020221268349PackageGS112In Commercial Distribution
00020221268348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022126834510020221268345
2002022126834220020221268342
3002022126834930020221268349
00020221268348000202212683480202212683480020221268348

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, Hevea-latex, single-useA strip or roll made of fabric with Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
180572216
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20020221260407EXEL Syringes26040260402016-09-20
20020221260421EXEL Syringes26042260422016-09-20
20020221260438EXEL Syringes26043260432016-09-20
20020221260445EXEL Syringes26044260442016-09-20
20020221260490EXEL Syringes26049260492016-09-20
20020221260506EXEL Syringes26050260502016-09-20
20020221261008EXEL Syringes26100261002016-09-20
20020221261015EXEL Syringes26101261012016-09-20
20020221261022EXEL Syringes26102261022016-09-20
20020221261039EXEL Syringes26103261032016-09-20
20020221261046EXEL Syringes26104261042016-09-20
20020221261053EXEL Syringes26105261052016-09-20
20020221261077EXEL Syringes26107261072016-09-20
20020221261084EXEL Syringes26108261082016-09-20
20020221261091EXEL Syringes26109261092016-09-20
20020221261107EXEL Syringes26110261102016-09-20
20020221261114EXEL Syringes26111261112016-09-20
20020221261121EXEL Syringes26112261122016-09-20
20020221261152EXEL Syringes26115261152016-09-20
20020221261169EXEL Syringes26116261162016-09-20

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