FDA.reportPublic FDA data

Epimed

Primary DI
05060224333341
Brand
Epimed
Company
MINTA MEDICAL LIMITED
Model
296-PARN
Catalog number
296-PARN
Device description
Adapter Assembly R-F™ Probe, Racz Neurostat
Published
2026-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K090608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090608000MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)Minta Medical Limited2010-06-14GXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060224333341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060224333341050602243333415060224333341

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical cable adaptorA small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)866-3342customerservice@epimed.com

Regulatory Flags#

DUNS number
232644059
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060224334607Epimed296-DPARN2026-10-07
05060224333150Epimed299-5299-52017-10-30
05060224333167Epimed299-10299-102017-10-30
05060224333174Epimed299-15299-152017-10-30
05060224333204Epimed299-5-IP299-5-IP2017-10-30
05060224333211Epimed299-10-IP299-10-IP2017-10-30
05060224333228Epimed299-15-IP299-15-IP2017-10-30
05060224334478Epimed296-DPA06X296-DPA06X2017-10-30
05060224334485Epimed296-DPA06N296-DPA06N2017-10-30
05060224334492Epimed296-DPA06S5296-DPA06S52017-10-30
05060224334508Epimed296-DPA06S10296-DPA06S102017-10-30
05060224334515Epimed296-DPA06S15296-DPA06S152017-10-30
05060224334522Epimed296-DPA06R296-DPA06R2017-10-30
05060224334539Epimed296-DPA06C296-DPA06C2017-10-30
05060224334546Epimed296-DPA120B296-DPA120B2017-10-30
05060224334553Epimed296-DPA06SN296-DPA06SN2017-10-30
05060224334560Epimed296-DPIA06B296-DPIA06B2017-10-30
05060224334577Epimed296-DPA06D296-DPA06D2017-10-30
05060224334584Epimed296-DPGA06B296-DPGA06B2017-10-30
05060224333051Epimed297-5297-52017-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060224334607EpimedMINTA MEDICAL LIMITEDGXI2026-10-07
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