Urology Traxer Flow 2 spikes SOUR9207ST12

GUDID 03700512922063

Traxer Flow DUAL PORT - Irrigation set for Laser Ureteroscopy - 2 spikes

Promepla

Surgical irrigation/aspiration tubing set
Primary Device ID03700512922063
NIH Device Record Key8b3496ea-e22c-45db-8bf4-22cad9f86ae0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrology Traxer Flow 2 spikes
Version Model NumberRF2URST
Catalog NumberSOUR9207ST12
Company DUNS401020409
Company NamePromepla
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103700512902065 [Primary]
GS103700512912064 [Package]
Contains: 03700512902065
Package: Box Label 1 [10 Units]
In Commercial Distribution
GS103700512922063 [Package]
Contains: 03700512912064
Package: Box Label 2 [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FHFSystem, Evacuator, Fluid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-11
Device Publish Date2019-10-21

Devices Manufactured by Promepla

03700512922001 - Urology TURP Gravity Tubing2020-02-11 Irrigation set for TURP / diagnostic
03700512901983 - Urology TraxerFlow Gravity Tubing2020-02-11 TRAXER FLOW use with gravity - Irrigation Line for Laser Ureteroscopy
03700512922087 - Urology TURP Post-Op Extra Spike2020-02-11 Irrigation/Aspiration set for RTUP/Post Operative irrigation (Urology) - 2 spikes - pump segment
03700512922070 - Urology Diagnostic TURP 2 Spike2020-02-11 Irrigation tubing set for RTUP/Diagonstic - 2 spikes
03700512922063 - Urology Traxer Flow 2 spikes2020-02-11Traxer Flow DUAL PORT - Irrigation set for Laser Ureteroscopy - 2 spikes
03700512922063 - Urology Traxer Flow 2 spikes2020-02-11 Traxer Flow DUAL PORT - Irrigation set for Laser Ureteroscopy - 2 spikes
03700512922056 - Urology TURP 2 Spike2020-02-11 Irrigation/Aspiration set for RTUP (Urology) - 2 spikes - pump segment
03700512922049 - Urology TURP Post-Op 2 Spike2020-02-11 Irrigation/Aspiration set for RTUP/Post Operative irrigation (Urology) - 2 spikes - pump segment
03700512922032 - Urology Trawer Flow 1 Spike2020-02-11 Traxer flow DUAL PORT - Irrigation set for Laser Ureteroscopy - 1 spike

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