FDA.reportPublic FDA data

Epimed

Primary DI
10818788022636
Brand
Epimed
Company
EPIMED INTERNATIONAL, INC
Model
287-2010
Catalog number
287-2010
Device description
R-F™ Cannula Coudé® B-Bevel 20g x 10cm w/ 10mm Active Tip
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
K041021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041021000RF INTRODUCTION CANNULAEpimed International, Inc.2004-09-16GXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818788022636PackageGS125In Commercial Distribution
20818788022633PackageGS110In Commercial Distribution
00818788022639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081878802263610818788022636
2081878802263320818788022633
00818788022639008187880226398187880226390818788022639

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system probe cannula, single-useA sterile rigid tube designed to provide body tissue access through its lumen for a radio-frequency (RF) probe during 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length10Centimeter
Length10Millimeter
Needle Gauge20Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
799751953
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818788022998Epimed International, Inc.104-13142026-03-17
10818788022995Epimed International, Inc.104-13142026-03-17
00818788022295Epimed International, Inc.401-PBSYS2025-12-05
00818788021892Epimed International, Inc.325-4LRFG325-4LRFG2025-11-21
00818788022943Epimed International, Inc258-2205258-22052025-11-21
00818788022950Epimed International, Inc259-2010259-20102025-11-21
00818788022967Epimed International, Inc284-2010284-20102025-11-21
00818788022981Epimed291-C04291-C042017-10-24
00818788023650Epimed282-16102024-06-04
00818788023667Epimed282-16152024-06-04
00818788023681Epimed107-1618107-16182023-11-21
00818788021472Epimed189-2340189-23402017-10-24
00818788021564Epimed270-2015270-20152017-10-24
00818788021922Epimed265-2010265-20102017-10-24
00818788021939Epimed265-2015265-20152017-10-24
00818788021977Epimed268-2010268-20102017-10-24
00818788022066Epimed268-2015268-20152017-10-24
00818788022097Epimed270-2010270-20102017-10-24
00818788023599Epimed125-1820T125-1820T2021-06-17
00818788021281Epimed170-2124170-21242017-10-24

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
10195327047030Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2022-08-04
00193493000265COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000272COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000296AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000302AVANOS*Avanos Medical, Inc.GXI2022-03-12