FDA.reportPublic FDA data

NRG Transseptal Needle

Primary DI
00685447000211
Brand
NRG Transseptal Needle
Company
BOSTON SCIENTIFIC CORPORATION
Model
NRG-E-HF-71-C1
Published
2016-08-15
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

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
00685447000211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447000211006854470002116854470002110685447000211

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
Length71Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

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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00850057445275HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445282HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445299HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445305HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01