FDA.report

Dermacea

Primary DI
50192253049280
Brand
Dermacea
Company
Cardinal Health 200, LLC
Model
441507
Catalog number
441507
Device description
Dermacea Stretch Bandage Roll
Published
2025-07-21
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

Product Codes

CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253049289PackageGS112In Commercial Distribution
50192253049280PackageGS14In Commercial Distribution
10192253049282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225304928920192253049289
5019225304928050192253049280
1019225304928210192253049282

GMDN Terms

TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes

TypeValueUnit
Length12Feet
Width6Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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