FDA.reportPublic FDA data

Quantum MIS Cannulated System

Primary DI
00846468050535
Brand
Quantum MIS Cannulated System
Company
Pioneer Surgical Technology, Inc.
Model
51-STIM-1
Catalog number
51-STIM-1
Device description
Nerve Monitoring Cable
Published
2020-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNSTIMULATOR, NERVE
GXZELECTRODE, NEEDLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073229000NERVE MONITORING CABLEPioneer Surgical Technology2008-06-06GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468050535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468050535008464680505358464680505350846468050535

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-function monitorA mains electricity (AC-powered) bedside device designed to continuously assess the adequacy of the nerve function of a non-ambulatory patient who requires monitoring (e.g., as a result of trauma, anaesthesia, intervention, evaluation). It typically monitors evoked potential (EP), electromyography (EMG), electroencephalography (EEG) and/or neuromuscular block response. It typically consists of electrodes applied to the patient intended to acquire the neural electrical signal, and a computerized unit to process and display the information; stimulation systems for nerve block and evoked potential evaluation are separate requirements.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846468049430nanOss ABGS90-100-0190-100-012015-12-14
00846468049447nanOss ABGS90-100-0290-100-022015-12-14
00846468049454nanOss ABGS90-100-0590-100-052015-12-14
00846468049461nanOss ABGS90-100-1090-100-102015-12-14
00846468049478nanOss ABGS90-100-2090-100-202015-12-14
00846468049515nanOss Loaded ABGS90-200-0590-200-052015-12-14
00846468049522nanOss Loaded ABGS90-200-1090-200-102015-12-14
00846468049546nanOss 3D ABGS90-300-2550490-300-255042015-12-14
00846468049553nanOss 3D ABGS90-300-2550890-300-255082015-12-14
00846468049560nanOss 3D ABGS90-300-25100490-300-2510042015-12-14
00846468049577nanOss 3D ABGS90-300-25100890-300-2510082015-12-14
00846468057411nanOss Loaded ABGS90-200-05K90-200-05K2015-12-14
00846468057428nanOss BA - Loaded90-200-10K90-200-10K2015-12-14
00846468087104nanOss® 3D Plus™90-400-2550490-400-255042018-09-19
00846468087111nanOss® 3D Plus™90-400-2550890-400-255082018-09-19
00846468087128nanOss® 3D Plus™90-400-25100890-400-2510082018-09-19
00846468087135nanOss® 3D Plus™90-400-25100490-400-2510042018-09-19
00840298703685CODA™ Anterior Cervical Plate System58-202230010S2022-30-010S2023-06-28
00840298703708CODA™ Anterior Cervical Plate System58-202230014S2022-30-014S2023-06-28
00840298701445CODA™ Anterior Cervical Plate System58-102201010S1022-01-010S2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662674000549DSG ConnectSPINEGUARDETN2026-10-22
00860010951705NeuralytixNEURALYTIX, LLCETN2026-10-19
00810161901562EARP NERVE CUFF ELECTRODE, 5MMRETROPSOAS TECHNOLOGIES, LLCETN2026-10-16
00810161901548EARP NERVE CUFF ELECTRODE, 3MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901555EARP NERVE CUFF ELECTRODE, 4MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901579EARP NERVE CUFF ELECTRODE, 6MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00816312028638Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-09
00816312028652Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-09
00816312028669Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-09
00816312028614Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-08
00816312028621Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-08
04250307604388N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHETN2026-10-01
10816312028673Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-09-21
05707480167579Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167593Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167609Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167630Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167661Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
08720791378462NeurosignTechnomed Engineering B.V.GXZ2026-08-14
08720791378486NeurosignTechnomed Engineering B.V.GXZ2026-08-14
08720791378509NeurosignTechnomed Engineering B.V.GXZ2026-08-14
08720791378523NeurosignTechnomed Engineering B.V.GXZ2026-08-14