FDA.report

CMC-X Thumb Stabilizer

Primary DI
00802357244652
Brand
CMC-X Thumb Stabilizer
Company
MEDICAL SPECIALTIES INCORPORATED
Model
224465
Published
2022-12-07
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
false

Related Records

Product Codes

CodeName
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00802357244652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357244652008023572446528023572446520802357244652

GMDN Terms

TermDefinition
Wrist orthosisA prefabricated (non-customized) externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
003173028
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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00802357236428ASO Speed Lacer II Ankle Stabilizer w/Stays2236422025-05-06
00802357236442ASO Speed Lacer II Ankle Stabilizer w/Stays2236442025-05-06
00802357236459ASO Speed Lacer II Ankle Stabilizer w/Stays2236452025-05-06
00802357236466ASO Speed Lacer II Ankle Stabilizer w/Stays2236462025-05-06
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00802357172320Gripper 3 Knee, 12" CoolFlex1172322025-01-14
00802357172344Gripper 3 Knee, 12" Coolflex1172342025-01-14
00802357172351Gripper 3 Knee, 12" Coolflex1172352025-01-14
00802357172368Gripper 3 Knee, 12" Coolflex1172362025-01-14
00802357172375Gripper 3 Knee, 12" Coolflex1172372025-01-14
00802357172382Gripper 3 Knee, 12" Coolflex1172382025-01-14
00802357172399Gripper 3 Knee, 12" Coolflex1172392025-01-14
00802357234400EPIGEL W/STAYS, UNIVERSAL2234402025-01-14
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00802357240029TRIPOD WRIST LACER II2240022025-01-14
00802357240043TRIPOD WRIST LACER II2240042025-01-14
00802357240050TRIPOD WRIST LACER II2240052025-01-14

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