FDA.reportPublic FDA data

CoreTech

Primary DI
10810041981155
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP2048BLK
Device description
627 LSO Back Brace (Black)
Published
2024-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ISRBand Or Belt, Pelvic Support

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISRBand Or Belt, Pelvic SupportPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041981155PackageGS110In Commercial Distribution
00810041981158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198115510810041981155
00810041981158008100419811588100419811580810041981158

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00810178883127ViveSUP3108S2026-07-21
00810178883134ViveSUP3108M2026-07-21
00810178883141ViveSUP3108L2026-07-21
00810178883158ViveSUP3108XL2026-07-21
00810226441217ViveLVA3173WOOD2026-07-21
00810226441224SuresLVA3174BFL2026-07-21
00810226441231SuresLVA3174BLK2026-07-21
00810226441248SuresLVA3174RPF2026-07-21
00810178889334SuresLVA2040NAV2026-07-17
00810178889341SuresLVA2040NAV2PAK2026-07-17
00810178889358SuresLVA2040NAV4PAK2026-07-17
00810226441156SuresLVA2040BLK2026-07-17
00810226441163SuresLVA2040BLK2PAK2026-07-17
00810226441170SuresLVA2040BLK4PAK2026-07-17
00810226441187SuresLVA2040TAN2026-07-17
00810226441194SuresLVA2040TAN2PAK2026-07-17
00810226441200SuresLVA2040TAN4PAK2026-07-17
00810226440593CoreTechSUP31702026-07-16
00818323020014ViveLVA10412026-07-16
00810226440623ViveSUP3168BGES2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776102239Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102246Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102253Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102260Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102277Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102819Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102826Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102833Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102840Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102857Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102864Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102871Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102888Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102956Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102963Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102970Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102987Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102994Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106800Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106817Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106824Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106831Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106848Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106855Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106862Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106879Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106886Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776106893Neotech CareNEOTECH CARE INC.ISR2026-07-22
04719879646603ComfyhealthComfy Health Group Co., Ltd.ISR2025-12-08
00810113683416Three in One Belly BandManamed, Inc.ISR2025-11-25