FDA.reportPublic FDA data

NRG Transseptal Needle

Primary DI
00685447004486
Brand
NRG Transseptal Needle
Company
Baylis Médicale Cie Inc
Model
NRG-E-89-C0
Published
2019-07-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXFCatheter, Septostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXFCatheter, SeptostomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073326000NRG TRANSSEPTAL NEEDLEBaylis Medical Co., Inc.2008-05-28DXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447004486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447004486006854470044866854470044860685447004486

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length89Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags#

DUNS number
249225954
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447018841VersaCross Connect Transseptal DilatorVXA12-84-35-PS-D1NA2023-08-15
00685447010487VersaCross Connect Transseptal Dilator VXA12-85-35-WM-D02022-05-19
00685447010531VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D1NA2022-05-19
00685447005247VersaCross Large Access Transseptal DilatorVLA125-35-67-D0NA2021-06-10
00685447005254VersaCross Large Access Transseptal DilatorVLA125-35-67-D1NA2021-06-10
00685447005261VersaCross Large Access Transseptal DilatorVLA125-35-85-D0NA2021-06-10
00685447005278VersaCross Large Access Transseptal DilatorVLA125-35-85-D1NA2021-06-10
00685447005735VersaCross Steerable SheathVST85-35-BD-71L-D0NA2021-04-08
00685447005759VersaCross Steerable SheathVST85-35-BD-71M-D0NA2021-04-08
00685447005766VersaCross Steerable SheathVST85-35-BD-71M-D1NA2021-04-08
00685447005780VersaCross Steerable SheathVST85-35-BD-71S-D1NA2021-04-08
00685447003380VersaCross Transseptal SheathVXS85-35-63-45-D02019-06-26
00685447003397VersaCross Transseptal SheathVXS85-35-63-55-D02019-06-26
00685447003281VersaCross RF WireVXW-35-180-J2019-05-01
00685447003298VersaCross RF WireVXW-35-180-P2019-05-01
00685447003304VersaCross RF WireVXW-35-230-J2019-05-01
00685447003311VersaCross RF WireVXW-35-230-P2019-05-01
00685447000938RFP-100A Connector CableRFX-BAY-OTW-12-SU2016-08-15
00685447001027Adult Dispersive ElectrodeRFA-GP-BAY2017-02-03
00685447011774VersaCross Access SolutionVXSK0026NA2022-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858769006487SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006500SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006524SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006531SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006548SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006555SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006488SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006494SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006501SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006517SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006525SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006532SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006549SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006556SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
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