NRG Transseptal Needle

GUDID 00685447000211

Baylis Médicale Cie Inc

Endoscopic electrosurgical electrode, monopolar, single-use

Primary Device ID	00685447000211
NIH Device Record Key	82b69eb0-6f19-4e53-9ef7-e8ac1dc730fe
Commercial Distribution Status	In Commercial Distribution
Brand Name	NRG Transseptal Needle
Version Model Number	NRG-E-HF-71-C1
Company DUNS	249225954
Company Name	Baylis Médicale Cie Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com

Device Dimensions

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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
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Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
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Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
Device Size Text, specify	0
Length	71 Centimeter
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Length	71 Centimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447000211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K073326

FDA Product Code

DXF	Catheter, Septostomy

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-08-15

On-Brand Devices [NRG Transseptal Needle]

00685447000259	NRG-E-HF-98-C1
00685447000242	NRG-E-HF-98-C0
00685447000235	NRG-E-HF-89-C1
00685447000228	NRG-E-HF-89-C0
00685447000211	NRG-E-HF-71-C1
00685447000204	NRG-E-HF-71-C0
00685447000198	NRG-E-98-C1
00685447000181	NRG-E-98-C0
00685447000174	NRG-E-89-C1
00685447000167	NRG-E-89-C0
00685447000150	NRG-E-71-C1
00685447000143	NRG-E-71-C0
00685447000136	NRG-E-56-32-C0
00685447000129	NRG-HF-98-C1
00685447000112	NRG-HF-98-C0
00685447000105	NRG-HF-89-C1
00685447000099	NRG-HF-89-C0
00685447000082	NRG-HF-71-C1
00685447000075	NRG-HF-71-C0
00685447000068	NRG-98-C1
00685447000051	NRG-98-C0
00685447000044	NRG-89-C1
00685447000037	NRG-89-C0
00685447000020	NRG-71-C1
00685447000013	NRG-71-C0
00685447000006	NRG-56-32-C0
00685447004585	NRG-E-56-32-C0
00685447004578	NRG-E-HF-98-C1
00685447004561	NRG-E-HF-98-C0
00685447004554	NRG-E-HF-89-C1
00685447004547	NRG-E-HF-89-C0
00685447004530	NRG-E-HF-71-C1
00685447004523	NRG-E-HF-71-C0
00685447004516	NRG-E-98-C1
00685447004509	NRG-E-98-C0
00685447004493	NRG-E-89-C1
00685447004486	NRG-E-89-C0
00685447004479	NRG-E-71-C1
00685447004462	NRG-E-71-C0
00685447004455	NRG-56-32-C0
00685447004448	NRG-HF-98-C1
00685447004431	NRG-HF-98-C0
00685447004424	NRG-HF-89-C1
00685447004417	NRG-HF-89-C0
00685447004400	NRG-HF-71-C1
00685447004394	NRG-HF-71-C0
00685447004387	NRG-98-C1
00685447004370	NRG-98-C0
00685447004363	NRG-89-C1
00685447004356	NRG-89-C0