FDA.report

DARCO® Bungee wrist brace

Primary DI
20609271101351
Brand
DARCO® Bungee wrist brace
Company
DARCO INTERNATIONAL, INC.
Model
9BW3R
Catalog number
9BW3R; BW3-R
Device description
Large Black Right
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
ILHSPLINT, HAND, AND COMPONENTS

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10609271101354PackageGS14In Commercial Distribution
20609271101351PackageGS112In Commercial Distribution
00609271101357PrimaryGS10

GMDN Terms

TermDefinition
Wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable 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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