Sensoronics

GUDID 00851456007682

SENSORONICS INCORPORATED

Electrocardiographic lead set, reusable
Primary Device ID00851456007682
NIH Device Record Key2108bd06-644f-499f-8a27-611d1b00f7be
Commercial Distribution StatusIn Commercial Distribution
Brand NameSensoronics
Version Model NumberSECG-PHP5L-TC1600
Company DUNS079579147
Company NameSENSORONICS INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851456007682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

On-Brand Devices [Sensoronics]

00851457007261SB-NCRON-3P
00851457007254SC-PH-8RH
00851457007247SC-SPNE-8REC
00851457007230SC-SPNE-8HYP
00851457007223SC-PHOXNE-8RH
00851457007216SC-PHOXNE-8HH
00851457007209SC-PH-8H
00851457007193SC-OXDOC-8
00851457007186SC-OX-8
00851457007179SC-OX-4
00851457007162SC-NESCP-8
00851457007155SC-MAR-5LNC
00851457007148SC-MA-4LNC
00851457007131SC-MA-10LNC
00851457007124SC-GEOX-8
00851457007117SC-GEOH-8
00851457007100SC-GENE-8
00851457007094SC-GEMAS-8
00851457007087SC-GEMA-8
00851457007070SC-OXNE-8
00851457007063SC-OXNE-4
00851457007056SC-MARNE-5
00851457007049SC-MANE-8LNC
00851457007032SC-MANE-8AMP
00851457007025SC-MANE-4LNC
00851457007018SC-GEMANE-8
00851457007001SRP-OHM-9P
00851456007996SRP-OHM-9A
00851456007989SRP-OHM-3P
00851456007972SRP-OHM-3A
00851456007965SRP-NON-3P
00851456007958SRP-NON-3A
00851456007941SRP-NCRO-9P
00851456007934SRP-NCRO-9A
00851456007927SRP-NCRO-3P
00851456007910SRP-NCRO-3A
00851456007903SRP-MALNC-3P
00851456007897SRP-MALNC-3A
00851456007880SRP-BCI-3P
00851456007873SRP-BCI-3A
00851456007774SFP-BCI-18A
00851456007729SECG-PHY6L-3
00851456007712SECG-PHY12L-TC8
00851456007705SECG-PHY12L-TC5
00851456007699SECG-PHP5L-TC1668
00851456007682SECG-PHP5L-TC1600
00851456007675SECG-PHP5L-TC1520
00851456007668SECG-PHP5L-1968
00851456007651SECG-PHP5L-1644
00851456007644SECG-PHP5L-1625

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