FDA.reportPublic FDA data

Cadwell

Primary DI
16955739000313
Brand
Cadwell
Company
Xi'an Friendship Medical Electronics Co.,Ltd.
Model
302427-000-200
Published
2022-04-29
Public version status
New
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
ETNStimulator, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112426000XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBESXian Friendship Medical Electronics Co., Ltd.2012-04-02ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26955739000310PackageGS110In Commercial Distribution
16955739000313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2695573900031026955739000310
1695573900031316955739000313

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system probe, single-useA hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.

Regulatory Flags#

DUNS number
529249095
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16955739010329Friendship MedicalNE-T-2000/17/0.402024-05-10
26955739010326Friendship MedicalNE-T-2000/17/0.402024-05-10
16955739012385Friendship MedicalNE-T-1500/13/0.4-GP22023-12-15
26955739012382Friendship MedicalNE-T-1500/13/0.4-GP22023-12-15
16955739012392Friendship MedicalNE-P-2500/13/0.4-GP22023-12-01
26955739012399Friendship MedicalNE-P-2500/13/0.4-GP22023-12-01
16955739012224Friendship MedicalNE-T-2500/18/0.42023-05-05
16955739012316Friendship MedicalNE-D1-2500/18/0.42023-06-27
26955739012313Friendship MedicalNE-D1-2500/18/0.42023-06-27
26955739012221Friendship MedicalNE-T-2500/18/0.42023-05-05
16955739012149Cadwell302822-000-060-GP22023-02-28
16955739012156Cadwell302822-000-100-GP22023-02-28
26955739012146Cadwell302822-000-060-GP22023-02-28
26955739012153Cadwell302822-000-100-GP22023-02-28
16955739000047Cadwell302852-000-0602022-04-29
16955739000054Cadwell302852-000-1002022-04-29
16955739000061Cadwell302853-000-0602022-04-29
16955739000078Cadwell302853-000-1002022-04-29
16955739000085Cadwell302854-000-0602022-04-29
16955739000092Cadwell302854-000-1002022-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
B006NVHS102NONENeurovision Medical Products, Inc.ETN2025-12-18
B006HGELS102NONENeurovision Medical Products, Inc.ETN2025-02-12
B006NVPS2Nerveäna+®Neurovision Medical Products, Inc.ETN2025-02-11
20763000842547Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842554Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842561Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
08720791376451Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376475Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376482Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791373634NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
08720791373665NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPMK1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPSTST2Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPT1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPUSB1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006IDKWSF51252ScorpionNeurovision Medical Products, Inc.ETN2023-09-01
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20