Primary Device ID | 07613327470888 |
NIH Device Record Key | d31e314d-e133-47d0-9b85-79086a62a5b8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Baylis Medical NRG |
Version Model Number | RFX-BAY-TS |
Catalog Number | RFX-BAY-TS |
Company DUNS | 020198912 |
Company Name | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Serial Number | true |
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 |
Phone | +1(888)888-3433 |
RegulatoryAffairs2@stryker.com |
Length | 10 Feet |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613327470888 [Primary] |
IKD | CABLE, ELECTRODE |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-10 |
Device Publish Date | 2022-09-30 |
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07613327465822 - N/A | 2023-12-08 |
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07613327601190 - N/A | 2023-02-24 EP Diagnostic Catheter, 22 pins |
07613327601251 - N/A | 2023-02-24 EP Catheter Cable, 34 Pin |