FDA.reportPublic FDA data

ClosureFast

Primary DI
10884521140202
Brand
ClosureFast
Company
Covidien LP
Model
CB-CO-4 x 5
Catalog number
CB-CO-4 x 5
Device description
"Compression Bandages,Cohesive,4"""" x 15' (10.16 cm x 4.572 m)"
Published
2018-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521140209PackageGS112Not in Commercial Distribution
10884521140202PrimaryGS10
30884521140206Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452114020920884521140209
1088452114020210884521140202
3088452114020630884521140206

GMDN Terms#

Term, Definition table
TermDefinition
Wound compression dressingA sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Feet
Width4Inch

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
12
Premarket exempt
true
Lot or batch
true

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