Home GUDID 50884908108199 TROCARTROCAR
Primary DI 50884908108199
Brand TROCARTROCAR
Company Medical Components, Inc.
Model FSX
Device description FALLER STYLET
Published 2016-10-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DRC Trocar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRC Trocar Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50884908108199 Package GS1 5 In Commercial Distribution 00884908108194 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 50884908108199 50884908108199 00884908108194 00884908108194 884908108194 0884908108194
GMDN Terms# Term, Definition table Term Definition Subcutaneous tunneller, single-use A sterile, hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a single-use device.
Regulatory Flags# DUNS number 038000253 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841731135391 Redemption VILEX LLC DRC 2026-01-12 10192253057218 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057225 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057232 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057249 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057256 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057263 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057287 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253065237 Argyle Cardinal Health 200, LLC DRC 2024-08-02 00858769006425 SafeSharp Transseptal Needle PPMDM DRC 2024-07-02 00858769006449 SafeSharp Transseptal Needle PPMDM DRC 2024-07-02 00858769006456 SafeSharp Transseptal Needle PPMDM DRC 2024-07-02 00858769006470 SafeSharp Transseptal Needle PPMDM DRC 2024-07-02 10884450412708 Merit Advance® Merit Medical Systems, Inc. DRC 2024-03-29 00858769006418 SafeSept Transseptal Guidewire PPMDM DRC 2022-09-26 00858769006364 SafeSept Blunt Needle PPMDM DRC 2021-03-15 00858769006371 SafeSept Blunt Needle PPMDM DRC 2021-03-15 00858769006388 SafeSept Blunt Needle PPMDM DRC 2021-03-15 00858769006395 SafeSept Blunt Needle PPMDM DRC 2021-03-15 00858769006401 SafeSept Blunt Needle PPMDM DRC 2021-03-15 M752TSBRF6640 Stradis Medical, LLC STRADIS MEDICAL LLC DRC 2020-10-26 M752TN170313069C0 Stradis Medical, LLC STRADIS MEDICAL LLC DRC 2020-06-16 00849233009059 Busse Hospital Diposables ROBERT BUSSE & CO., INC. DRC 2020-04-08 00858769006197 Transseptal Needle PPMDM DRC 2018-11-28 00858769006203 Transseptal Needle PPMDM DRC 2018-11-28 00858769006210 Transseptal Needle PPMDM DRC 2018-11-28 00858769006241 Transseptal Needle PPMDM DRC 2018-11-28 00858769006258 Transseptal Needle PPMDM DRC 2018-11-28 10884450151850 Merit Advance® Merit Medical Systems, Inc. DRC 2018-06-11 00858769006104 SafeSept Transseptal Guidwire PPMDM DRC 2018-03-02