FDA.report

VQ ORTHOCARE

Primary DI
00817717022320
Brand
VQ ORTHOCARE
Company
V Q Orthocare
Model
09-12996-002
Device description
OACTIVE ALIGN CUSTOM HD L
Published
2022-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IQIOrthosis, Limb Brace

Product Code Classifications

CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817717022320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817717022320008177170223208177170223200817717022320

GMDN Terms

TermDefinition
Knee orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
601204902
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817717020456VQ ORTHOCARE08-22006-0012022-03-21
00817717020463VQ ORTHOCARE08-22006-0022022-03-19
00817717020470VQ ORTHOCARE08-22996-0012022-03-19
00817717020487VQ ORTHOCARE08-22996-0022022-03-19
00817717020494VQ ORTHOCARE08-22008-0012022-03-19
00817717020500VQ ORTHOCARE08-22008-0022022-03-19
00817717020517VQ ORTHOCARE08-22998-0012022-03-19
00817717020524VQ ORTHOCARE08-22998-0022022-03-19
00817717020531VQ ORTHOCARE08-32006-0012022-03-19
00817717020548VQ ORTHOCARE08-32006-0022022-03-19
00817717020555VQ ORTHOCARE08-32996-0012022-03-19
00817717020562VQ ORTHOCARE08-32996-0022022-03-19
00817717020579VQ ORTHOCARE08-32008-0012022-03-19
00817717020586VQ ORTHOCARE08-32008-0022022-03-19
00817717020593VQ ORTHOCARE08-32998-0012022-03-19
00817717020609VQ ORTHOCARE08-32998-0022022-03-19
00817717020616VQ ORTHOCARE07-41003-0012022-03-19
00817717020623VQ ORTHOCARE07-41004-0012022-03-19
00817717020630VQ ORTHOCARE07-42203-0012022-03-19
00817717020647VQ ORTHOCARE07-42204-0012022-03-19

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