FDA.report

Wrist Lacer

Primary DI
00802357239665
Brand
Wrist Lacer
Company
MEDICAL SPECIALTIES INCORPORATED
Model
223966
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
00802357239665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357239665008023572396658023572396650802357239665

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

Other Devices From This Company

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00802357230846Tee Pee Thumb Protector2230842022-12-08
00802357236411ASO Speed Lacer II Ankle Stabilizer w/Stays2236412025-05-06
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
00802357236473ASO Speed Lacer II Ankle Stabilizer w/Stays2236472025-05-06
00802357172313Gripper 3 Knee, 12" CoolFlex1172312025-01-14
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
00802357240012TRIPOD WRIST LACER II2240012025-01-14
00802357240029TRIPOD WRIST LACER II2240022025-01-14
00802357240043TRIPOD WRIST LACER II2240042025-01-14
00802357240050TRIPOD WRIST LACER II2240052025-01-14

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