FDA.reportPublic FDA data

Universal Elastic Rib Belt

Primary DI
00802357632602
Brand
Universal Elastic Rib Belt
Company
MEDICAL SPECIALTIES INCORPORATED
Model
163260
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

Product Codes#

Code, Name table
CodeName
FSDBinder, Abdominal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802357632602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357632602008023576326028023576326020802357632602

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic spine orthosisA prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device.

Sterilization Methods#

Method table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975740361596MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
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06975740361992MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362005MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362173MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
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06975740362197MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
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00190446660217PROCAREDJO, LLCFSD2025-05-14
00190446660279PROCAREDJO, LLCFSD2025-05-14
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00190446660293PROCAREDJO, LLCFSD2025-05-14
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00190446660767PROCAREDJO, LLCFSD2025-05-14