FDA.report

DARCO® Body Armor® Elastic Tape, strong (pink)

Primary DI
20609271629909
Brand
DARCO® Body Armor® Elastic Tape, strong (pink)
Company
DARCO INTERNATIONAL, INC.
Model
BAET-P
Catalog number
BAET-P
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KGXTape and bandage, adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20609271629909PackageGS136In Commercial Distribution
00609271629905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2060927162990920609271629909
00609271629905006092716299056092716299050609271629905

GMDN Terms

TermDefinition
Limb immobilization/support skin adhesive tapeA flexible band of fabric, plastic, or other material intended to noninvasively adhere to the skin surface to immobilize a joint and/or support a limb. It may be referred to as sports tape, functional tape, or kinesiology tape and is coated on one side with a pressure-sensitive adhesive and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184231298
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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