FDA.report

NRG RF Transseptal Kit

Primary DI
00685447014362
Brand
NRG RF Transseptal Kit
Company
Baylis Médicale Cie Inc
Model
NTK-P710-8590S
Device description
1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire
Published
2022-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DXFCatheter, Septostomy

Product Code Classifications

CodeDeviceSpecialtyClass
DXFCatheter, SeptostomyCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00685447014362PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00685447014362140068544701436206854470143620685447014362Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

TermDefinition
Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags

DUNS number
249225954
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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00685447019466VersaCross Connect™ LAAC Access SolutionVXAK0101VXAK01012025-02-25
00685447019473VersaCross Connect™ LAAC Access SolutionVXAK0103VXAK01032025-02-25
00685447019480VersaCross Connect™ LAAC Access SolutionVXAK0105VXAK01052025-02-25
00685447019497VersaCross Connect™ LAAC Access SolutionVXAK0107VXAK01072025-02-25
00685447019503VersaCross Connect™ LAAC Access SolutionVXAK0109VXAK01092025-02-25
00685447019558VersaCross™ Large Access SolutionVLAK0102VLAK01022025-02-25
00685447019565VersaCross™ Large Access SolutionVLAK0109VLAK01092025-02-25
00685447019572VersaCross™ Large Access SolutionVLAK0110VLAK01102025-02-25
00685447019589VersaCross™ Large Access SolutionVLAK0113VLAK01132025-02-25
00685447019596VersaCross™ Large Access SolutionVLAK0114VLAK01142025-02-25
00685447019602VersaCross™ Steerable Access SolutionVSTK0102VSTK01022025-02-25
00685447019619VersaCross™ Steerable Access SolutionVSTK0103VSTK01032025-02-25
00685447019626VersaCross™ Steerable Access SolutionVSTK0104VSTK01042025-02-25
00685447019633VersaCross™ Steerable Access SolutionVSTK0106VSTK01062025-02-25
00685447019640VersaCross™ Steerable Access SolutionVSTK0114VSTK01142025-02-25
00685447019657VersaCross™ Steerable Access SolutionVSTK0115VSTK01152025-02-25
00685447019664VersaCross™ Steerable Access SolutionVSTK0116VSTK01162025-02-25
00685447019671VersaCross™ Steerable Access SolutionVSTK0117VSTK01172025-02-25
00685447019688VersaCross™ Steerable Access SolutionVSTK0118VSTK01182025-02-25
00685447019695VersaCross™ Steerable Access SolutionVSTK0120VSTK01202025-02-25

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Primary DIBrandCompanyProduct codePublished
30858769006488SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
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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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