FDA.report

CoreTech

Primary DI
10810041985986
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP2074BLK
Device description
Cervical Collar (3")
Published
2023-06-23
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

Related Records

Product Codes

CodeName
IQKOrthosis, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810041985986PackageGS140In Commercial Distribution
00810041985989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198598610810041985986
00810041985989008100419859898100419859890810041985989

GMDN Terms

TermDefinition
Cervical spine collar, reusableA prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a reusable device.

Sterilization Methods

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
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 DIBrandModelCatalogPublished
00810178883943ViveSUP3111BLK2026-03-06
00810178884506ViveMOB1141BLK322026-03-06
00810178884643ViveMOB1142BLK2026-03-06
00810178884766ViveMOB1144GRY2026-03-06
00810178884773ViveMOB1144BLU2026-03-06
00810178884780ViveMOB1144PNK2026-03-06
00810178885213ViveMOB1139BLK262026-03-06
00810178885220ViveMOB1139BLK282026-03-06
00810178885237ViveMOB1139BLK302026-03-06
00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
00810178887392Vive MobilityMOB1079GRY2026-02-18
00810178886890ViveSUP2019BGEXS2026-02-17
00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16946430425079Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDIQK2025-12-24
16974500613606 Cervical CollarGCMEDICA ENTERPRISE LTD.(WUXI)IQK2025-12-12
00749756399395DeRoyalDEROYAL INDUSTRIES, INC.IQK2025-07-23
00749756399401DeRoyalDEROYAL INDUSTRIES, INC.IQK2025-07-23
10810113578801ViveVIVE HEALTH LLCIQK2025-07-08
04823097718131TM "Rehabilitimed" ORTEZ-2V-1 XL-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718148TM "Rehabilitimed" ORTEZ-2V-1 XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718155TM "Rehabilitimed" ORTEZ-2V-1 XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097718162TM "Rehabilitimed" ORTEZ-2V-1 L-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718179TM "Rehabilitimed" ORTEZ-2V-1 L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718186TM "Rehabilitimed" ORTEZ-2V-1 L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097718193TM "Rehabilitimed" ORTEZ-2V-1 M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718209TM "Rehabilitimed" ORTEZ-2V-1 M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718216TM "Rehabilitimed" ORTEZ-2V-1 M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719701TM "Rehabilitimed" ORTEZ-2V-1 M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719718TM "Rehabilitimed" ORTEZ-2V-1 L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719725TM "Rehabilitimed" ORTEZ-2V-1 XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719732TM "Rehabilitimed" ORTEZ-2V-1 M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719749TM "Rehabilitimed" ORTEZ-2V-1 L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719756TM "Rehabilitimed" ORTEZ-2V-1 XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719763TM "Rehabilitimed" ORTEZ-2V-1 M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719770TM "Rehabilitimed" ORTEZ-2V-1 L-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719787TM "Rehabilitimed" ORTEZ-2V-1 XL-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719909TM "Rehabilitimed" ORTEZ-2V M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719916TM "Rehabilitimed" ORTEZ-2V L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719923TM "Rehabilitimed" ORTEZ-2V XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719930TM "Rehabilitimed" ORTEZ-2V M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719947TM "Rehabilitimed" ORTEZ-2V L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719954TM "Rehabilitimed" ORTEZ-2V XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719961TM "Rehabilitimed" ORTEZ-2V M-110 ComfortREABILITIMED TOVIQK2025-05-04