NRG Transseptal Needle

GUDID 00685447004516

Baylis Médicale Cie Inc

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00685447004516
• NIH Device Record Key: fbc57740-d8c6-440f-9d65-987253fd828d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NRG Transseptal Needle
• Version Model Number: NRG-E-98-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
• 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
• 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

• Length: 98 Centimeter
• Device Size Text, specify: 0
• Length: 98 Centimeter
• Device Size Text, specify: 0
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• Length: 98 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447004516 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-18
• Device Publish Date: 2019-07-10

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