FDA.reportPublic FDA data

Nimbus Probe (Disposable)

Primary DI
05060224332016
Brand
Nimbus Probe (Disposable)
Company
Stratus Medical LLC
Model
NDP-100-27-SS
Device description
Disposable RF Thermocouple Electrode
Published
2022-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
05060224336922PackageGS110In Commercial Distribution
05060224332016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060224336922050602243369225060224336922
05060224332016050602243320165060224332016

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe, denervation, monopolar, single-useA 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 or a tubing set to allow fluid cooling of the electrode may be included. This is a single-use device.

Storage And Handling#

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

Regulatory Flags#

DUNS number
117402924
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040767001NimbusNIM-100-10BB2022-09-12
00850040767018NimbusNIM-100-10BB-CS2022-09-12
00850040767025NimbusNIM-150-10BB2022-09-12
00850040767032NimbusNIM-050-10BB2022-09-12
00850040767049VestaNLT-100-18-10-BB2022-09-12
00850040767056VestaNLT-100-18-10-CH2022-09-12
00850040767063VestaNLT-100-18-10-CS2022-09-12
00850040767070VestaNLT-100-20-10-BB2022-09-12
00850040767087VestaNLT-100-20-10-CH2022-09-12
00850040767094VestaNLT-100-20-10-CS2022-09-12
00850040767100VestaNLT-100-22-05-BB2022-09-12
00850040767117VestaNLT-100-22-10-BB2022-09-12
00850040767124VestaNLT-100-22-10-CH2022-09-12
00850040767131VestaNLT-100-22-10-CS2022-09-12
00850040767148VestaNLT-150-18-10-BB2022-09-12
00850040767155VestaNLT-150-18-10-CH2022-09-12
00850040767162VestaNLT-150-18-10-CS2022-09-12
00850040767179VestaNLT-150-20-10-BB2022-09-12
00850040767186VestaNLT-150-20-10-CH2022-09-12
00850040767193VestaNLT-150-20-10-CS2022-09-12

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