FDA.reportPublic FDA data

Accurian

Primary DI
00763000710163
Brand
Accurian
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
APSC09
Device description
PROBE APSC09 100MM 7MM-2MM TIP ENHANCED
Published
2023-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXIProbe, radiofrequency lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181864000Polaris RF Ablation SystemBaylis Medical Company, Inc.2019-01-02GXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000710163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000710163007630007101637630007101630763000710163

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system probe cannula, single-useA rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between -20°C and 50°C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal System39910272026-08-27
00763000704117MSB CAPSTONE CONTROL™ Spinal System39910322026-08-27
00763000704124MSB CAPSTONE CONTROL™ Spinal System39911222026-08-27
00763000704131MSB CAPSTONE CONTROL™ Spinal System39911272026-08-27
00763000704148MSB CAPSTONE CONTROL™ Spinal System39911322026-08-27
00763000704155MSB CAPSTONE CONTROL™ Spinal System39912222026-08-27
00763000704162MSB CAPSTONE CONTROL™ Spinal System39912272026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223070291RGNPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070321RGNPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070727RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070758RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070772RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223084939ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085257ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085264ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085387ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085394ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085424ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085431ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085448ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085455ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
10884450452346ViaVerte™Merit Medical Systems, Inc.GXI2026-05-19
07613327601121OptaBlateSTRYKER CORPORATIONGXI2025-05-27
07613327601169OptaBlateSTRYKER CORPORATIONGXI2025-05-27
10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SST221505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
10195327493172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
20763000835631AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835648AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835655AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
00852454006240IntraceptRelievant Medsystems, Inc.GXI2023-04-20
00852454006257IntraceptRelievant Medsystems, Inc.GXI2023-04-20
10195327047030Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2022-08-04
00193493000265COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000272COOLIEF*Avanos Medical, Inc.GXI2022-03-17