FDA.reportPublic FDA data

CERVMAX®

Primary DI
00650551145257
Brand
CERVMAX®
Company
PMT CORPORATION
Model
1585B
Device description
CERVMAX CERVICAL COLLAR, SHORT, WITH EXTRA REPLACEMENT PAD
Published
2025-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IQKOrthosis, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551145257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551145257006505511452576505511452570650551145257

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine collar, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039576871
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650551006572DEPTHALON®2102-06-005-NS2026-05-26
00650551006589DEPTHALON®2102-06-0052026-05-26
00650551005537DEPTHALON®2104-04-32-0012026-05-18
00650551005865MICROMAT®3105-M-B-122026-05-18
00650551005872MICROMAT®3105-M-Y-122026-05-18
00650551006022INTEGRA3610-76-ST2026-05-18
00650551006039INTEGRA3610-76-2-ST2026-05-18
00650551006046INTEGRA3611-690-2-ST2026-05-18
00650551006060INTEGRA3610-636-3-ST2026-05-18
00650551006077INTEGRA3611-230-2-ST2026-05-18
00650551006084INTEGRA3614-42-2-ST2026-05-18
00650551006091INTERCONNECTION CABLE2127-12-01-087-QDC2026-05-18
00650551006114CORTAC®2110-64-1692026-05-18
00650551006138DEPTHALON®2102-02-1912026-05-18
00650551006145INTERCONNECTION CABLE2127-16-04-Y92026-05-18
00650551006176INTEGRA3614-14-2-IR2026-05-18
00650551006220INTERCONNECTION CABLE2120-10-0102026-05-18
00650551006237INTEGRA3611-691-IR-ST2026-05-18
00650551006459INTERCONNECTION CABLE2120-16-01-0112026-05-18
00650551006480INTERCONNECTION CABLE2127-16-04-Y10-NS2026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
04823097718131"TM ""Rehabilitimed"" ORTEZ-2V-1 XL-110 Comfort"REABILITIMED TOVIQK2025-05-04
04823097718148"TM ""Rehabilitimed"" ORTEZ-2V-1 XL-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097718155"TM ""Rehabilitimed"" ORTEZ-2V-1 XL-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097718162"TM ""Rehabilitimed"" ORTEZ-2V-1 L-110 Comfort"REABILITIMED TOVIQK2025-05-04
04823097718179"TM ""Rehabilitimed"" ORTEZ-2V-1 L-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097718186"TM ""Rehabilitimed"" ORTEZ-2V-1 L-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097718193"TM ""Rehabilitimed"" ORTEZ-2V-1 M-110 Comfort"REABILITIMED TOVIQK2025-05-04
04823097718209"TM ""Rehabilitimed"" ORTEZ-2V-1 M-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097718216"TM ""Rehabilitimed"" ORTEZ-2V-1 M-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719701"TM ""Rehabilitimed"" ORTEZ-2V-1 M-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719718"TM ""Rehabilitimed"" ORTEZ-2V-1 L-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719725"TM ""Rehabilitimed"" ORTEZ-2V-1 XL-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719732"TM ""Rehabilitimed"" ORTEZ-2V-1 M-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719749"TM ""Rehabilitimed"" ORTEZ-2V-1 L-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719756"TM ""Rehabilitimed"" ORTEZ-2V-1 XL-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719763"TM ""Rehabilitimed"" ORTEZ-2V-1 M-110 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719770"TM ""Rehabilitimed"" ORTEZ-2V-1 L-110 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719787"TM ""Rehabilitimed"" ORTEZ-2V-1 XL-110 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719909"TM ""Rehabilitimed"" ORTEZ-2V M-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719916"TM ""Rehabilitimed"" ORTEZ-2V L-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719923"TM ""Rehabilitimed"" ORTEZ-2V XL-75 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719930"TM ""Rehabilitimed"" ORTEZ-2V M-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719947"TM ""Rehabilitimed"" ORTEZ-2V L-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719954"TM ""Rehabilitimed"" ORTEZ-2V XL-90 Comfort"REABILITIMED TOVIQK2025-05-04
04823097719961"TM ""Rehabilitimed"" ORTEZ-2V M-110 Comfort"REABILITIMED TOVIQK2025-05-04