FDA.reportPublic FDA data

PMT CORPORATION - STEREOTACTIC

Primary DI
00650551144052
Brand
PMT CORPORATION - STEREOTACTIC
Company
PMT CORPORATION
Model
2103-177
Device description
SEEG REDUCING SYSTEM FOR VISUALASE ANCHOR BOLT
Published
2021-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970418000PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)Pmt Corp.1997-04-29GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551144052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551144052006505511440526505511440520650551144052

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10650551093616NEW BEGINNINGS® GEL SHEETING3505-12025-03-19
10650551093623NEW BEGINNINGS® GELSHAPES®3505-102025-03-19
10650551093630NEW BEGINNINGS® GELSHAPES®3505-112025-03-19
10650551093647NEW BEGINNINGS® GELSHAPES®3505-122025-03-19
10650551093654NEW BEGINNINGS® GELSHAPES®3505-22025-03-19
10650551093661NEW BEGINNINGS® GELSHAPES®3505-32025-03-19
10650551093678NEW BEGINNINGS® GELSHAPES®3505-42025-03-19
10650551093685NEW BEGINNINGS® GELSHAPES®3505-52025-03-19
10650551093692NEW BEGINNINGS® GELSHAPES®3505-82025-03-19
20650551093613NEW BEGINNINGS® GEL SHEETING3505-1-62025-03-19
20650551093620NEW BEGINNINGS® GELSHAPES®3505-10-62025-03-19
00650551006978PMT® SUCTION INSTRUMENTS9002-07-100-ST2026-07-20
00650551006992CORTAC®2110-08-1452026-07-20
00650551006794ILSO™1515-08SF2026-07-18
00650551006800ILSO™1515-08MF2026-07-17
00650551006817ILSO™1515-08LF2026-07-17
00650551006824ILSO™1515-08XF2026-07-17
00650551006831ILSO™1515-08SM2026-07-17
00650551006848ILSO™1515-08MM2026-07-17
00650551006855ILSO™1515-08LM2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290018179000Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179017Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179024Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179031Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179048Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179055Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179062Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179079Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179086Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179093Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
00650551006749DEPTHALON®PMT CORPORATIONGZL2026-06-09
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00650551005537DEPTHALON®PMT CORPORATIONGZL2026-05-18
00650551006138DEPTHALON®PMT CORPORATIONGZL2026-05-18
00650551005544DEPTHALON®PMT CORPORATIONGZL2026-05-15
00650551005919DEPTHALON®PMT CORPORATIONGZL2026-05-15
00650551005926DEPTHALON®PMT CORPORATIONGZL2026-05-15
00841823108814Anchor Bolt Kit, LSB StyleAd-Tech Medical Instrument CorporationGZL2026-04-08
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10873263009410microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
10873263008789microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008796microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
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10873263008819microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008826microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008833microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008840microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008857microTargeting™ ElectrodeFHC, INC.GZL2025-04-30