BIOC6-YMR/MST4-SA

GUDID 10888551006132

EP CABLE 4 PIN SHIELDED YELLOW

STERILMED, INC.

Electrical-only medical device connection cable, reprocessed
Primary Device ID10888551006132
NIH Device Record Key92999732-06ba-4465-8b78-c40c2ff75cc7
Commercial Distribution Discontinuation2019-04-17
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberBIOC6-YMR/MST4-SA
Catalog NumberBIOC6-YMR/MST4-SA
Company DUNS175899459
Company NameSTERILMED, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)541-0078
Emailcustomerservice@sterilmed.com
Phone+1(888)541-0078
Emailcustomerservice@sterilmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888551006132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NLHCATHETER, RECORDING, ELECTRODE, REPROCESSED

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551006132]

Ethylene Oxide


[10888551006132]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-17
Device Publish Date2016-09-22

Devices Manufactured by STERILMED, INC.

10888551045179 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045186 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551045193 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045209 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551010313 - NA2021-01-22 KNIFE SET ECTRA II (PACK OF 3)
10888551021531 - NA2021-01-22 KNIVES (1) HOOK BLADE (1) TRIANGLE BLADE ENDOTRAC BLADE SYSTEM
10888551000048 - NA2020-11-06 CTS RELIEF KIT, 5PC SET
10888551012928 - NA2020-10-19 ENDO LUNG

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.