Urology Diagnostic TURP 2 Spike SOUR9208ST12

GUDID 03700512922070

Irrigation tubing set for RTUP/Diagonstic - 2 spikes

Promepla

Surgical irrigation/aspiration tubing set
Primary Device ID03700512922070
NIH Device Record Keyc5a9608d-709a-4481-913b-90c2b52e1433
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrology Diagnostic TURP 2 Spike
Version Model NumberRF2TUPD
Catalog NumberSOUR9208ST12
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
GS103700512902072 [Primary]
GS103700512912071 [Package]
Contains: 03700512902072
Package: Box Label 1 [10 Units]
In Commercial Distribution
GS103700512922070 [Package]
Contains: 03700512912071
Package: Box Label 2 [2 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 Spike2020-02-11Irrigation tubing set for RTUP/Diagonstic - 2 spikes
03700512922070 - Urology Diagnostic TURP 2 Spike2020-02-11 Irrigation tubing set for RTUP/Diagonstic - 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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