FDA.reportPublic FDA data

HALO VEST LINER

Primary DI
00650551042860
Brand
HALO VEST LINER
Company
PMT CORPORATION
Model
1203-10M
Device description
1203-5 VEST LAMBSWOOL LINER MEDIUM
Published
2025-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAXTong, Skull For Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAXTong, Skull For TractionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090733000PMT HALO SYSTEMPmt Corp.2009-07-28HAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551042860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551042860006505510428606505510428600650551042860

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine immobilization system, single-useAn assembly of orthopaedic devices designed to immobilize the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. Commonly known as a Halo vest, it typically consists of a ring(s) around the head (the halo) which is attached to the skull with threaded bolts, a special padded vest/harness, four rods with locking mechanisms connecting the head ring to the vest, together with the appropriate instrumentation. This device may be made of ferrous or non-ferromagnetically active materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039576871
Device count
1
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
00650551006701PMT CORPORATION - STEREOTACTIC2103-15-20-NS2026-06-09
00650551006718PMT CORPORATION - STEREOTACTIC2103-15-25-NS2026-06-09
00650551006725PMT CORPORATION - STEREOTACTIC2103-15-30-NS2026-06-09
00650551006732PMT CORPORATION - STEREOTACTIC2103-15-35-NS2026-06-09
00650551006749DEPTHALON®2102-09-195-NS2026-06-09
00650551006633CORTAC®2110-04-0832026-06-04
00650551006640CORTAC®2110-08-1442026-06-04
00650551006657CORTAC®2110-16-1362026-06-04
00650551006664CORTAC®2110-20-1172026-06-04
00650551006671CORTAC®2110-32-1432026-06-04
00650551006688CORTAC®2110-48-1122026-06-04
00650551006695CORTAC®2110-64-1702026-06-04
00650551006602PMT CORPORATION2127-16-01-088-QDC2026-06-01
00650551006619PMT CORPORATION2127-16-01-089-QDC2026-06-01
00650551006626PMT CORPORATION2127-16-01-090-QDC2026-06-01
00650551006596INTEGRA3610-638-2I-ST62026-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551003861HALO TRAUMA KITPMT CORPORATIONHAX2025-03-10
00650551004417HALO TRAUMA KITPMT CORPORATIONHAX2025-03-10
00650551004424HALO RINGPMT CORPORATIONHAX2025-03-10
00650551004790HALO RINGPMT CORPORATIONHAX2025-03-10
00650551042006HALO RINGPMT CORPORATIONHAX2025-03-10
00650551042556HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042563HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042570HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042587HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042594HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042600HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042617HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042624HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042631HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042648HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042655HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042792HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042808HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042815HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042822HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042839HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042846HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042853HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042877HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042884HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042891HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551045052HALO RINGPMT CORPORATIONHAX2025-03-10
00650551045069HALO RINGPMT CORPORATIONHAX2025-03-10
00650551093923HALO SYSTEM COMPONENTPMT CORPORATIONHAX2025-03-10
00650551096252HALO RINGPMT CORPORATIONHAX2025-03-10