FDA.reportPublic FDA data

MECRON Wrist Guard L: 23 cm, U: 19-22 cm

Primary DI
10609271950839
Brand
MECRON Wrist Guard L: 23 cm, U: 19-22 cm
Company
DARCO INTERNATIONAL, INC.
Model
OS233102
Catalog number
OS233102
Device description
L Blue 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

Product Codes#

Code, Name table
CodeName
ILHSPLINT, HAND, AND COMPONENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271950839PackageGS112In Commercial Distribution
00609271950832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927195083910609271950839
00609271950832006092719508326092719508320609271950832

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20609271989607Aircore™ InsoleACIP0602026-01-07
20609271989614Aircore™ InsoleACIP0702026-01-07
20609271989621Aircore™ InsoleACIP0752026-01-07
20609271989638Aircore™ InsoleACIP0802026-01-07
00609271989641Aircore™ InsoleACIP0852026-01-07
20609271989652Aircore™ InsoleACIP0902026-01-07
20609271989669Aircore™ InsoleACIP0952026-01-07
20609271989676Aircore™ InsoleACIP1002026-01-07
20609271989683Aircore™ InsoleACIP1052026-01-07
20609271989690Aircore™ InsoleACIP1102026-01-07
20609271989706Aircore™ InsoleACIP1152026-01-07
20609271989713Aircore™ InsoleACIP1202026-01-07
20609271989720Aircore™ InsoleACIP1252026-01-07
20609271989737Aircore™ InsoleACIP1302026-01-07
20609271989744Aircore™ InsoleACIP1352026-01-07
20609271989751Aircore™ InsoleACIP1452026-01-07
20609271989768Aircore™ InsoleACIP1552026-01-07
00609271120167POGO™ PulsusPGP060NPGP060N2025-04-15
00609271120174POGO™ PulsusPGP070NPGP070N2025-04-15
00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817355022805KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-05
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