FDA.report

electrodeTCD

Primary DI
08132500143580
Brand
electrodeTCD
Company
COSMAN MEDICAL, LLC
Model
TCD-5-3M
Device description
Electrode 5cm, 28G
Published
2016-10-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXIProbe, Radiofrequency Lesion

Product Code Classifications

CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08132500143894PackageGS110Not in Commercial Distribution
08132500143580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08132500143894081325001438948132500143894
08132500143580081325001435808132500143580

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
781-272-6561orders@cosmanmedical.com

Regulatory Flags

DUNS number
184200736
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
08132500133826FlextrodeFLEX-K151320-5P2016-10-07
08132500158676tubingCTCCTC-TUBE2016-10-21
08132500159116tubingCTCCTC-R2016-10-21
08132500159284electrodeCTCCTC-E752016-10-21
08132500159352electrodeCTCCTC-E1502016-10-21
08132500159598cannulaCTCCTC-C7542016-10-21
08132500159734cannulaCTCCTC-C15042016-10-21
08132500160174cannulaEchoVUCC5521VU2016-10-20
08132500160242cannulaEchoVUCC101021VU2016-10-19
08132500160310cannulaEchoVUCC151021VU2016-10-19
08132500160792electrodeEchoCRCR-6522U2016-10-21
08132500160860electrodeEchoCRCR-10522U2016-10-20
08132500161096cannulaCCCC52222016-10-20
08132500161232electrodeCUCU-610222016-10-24
08132500161478electrodeCUCU-1010222016-10-21
08132500161614electrodeCUCU-1510222016-10-21
08132500161850electrodeEchoCUCU-61022U2016-10-24
08132500162086electrodeEchoCUCU-101022U2016-10-21
08132500162222electrodeEchoCUCU-151022U2016-10-21
08132500162468electrodeEchoCUCU-6520U2016-10-24

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04048223050132RFTLPajunk GmbH MedizintechnologieGXI2025-01-30
04048223050484RFTL SonoPajunk GmbH MedizintechnologieGXI2025-01-30
00856895008634OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008641OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXI2024-12-02
40195327666355Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
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M661SCV220505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
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M661SCV221005Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18