FDA.reportPublic FDA data

Epimed

Primary DI
05060224334584
Brand
Epimed
Company
MINTA MEDICAL LIMITED
Model
296-DPGA06B
Catalog number
296-DPGA06B
Device description
Adapter Assembly Disposable R-F™ Probe, Baylis Ground
Published
2017-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
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
05060224334584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060224334584050602243345845060224334584

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous electrosurgical probe, denervation, monopolar, single-useA sterile, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under external image guidance or using electrical stimulation for nerve location] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
232644059
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05060224333051Epimed297-5297-52017-10-30
05060224333068Epimed297-10297-102017-10-30
05060224333075Epimed297-15297-152017-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00193493000326COOLIEF*Avanos Medical, Inc.GXI2022-03-12
00193493985920AVANOS*Avanos Medical, Inc.GXI2022-03-12
00191506013097SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013103SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013110SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013127SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00193493000159AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000166AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000173AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000197AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000203AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478804AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478811AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478828AVANOSAvanos Medical, Inc.GXI2021-03-11