Urology TURP 2 Spike SOUR9201ST12

GUDID 03700512922056

Irrigation/Aspiration set for RTUP (Urology) - 2 spikes - pump segment

Promepla

Surgical irrigation/aspiration tubing set
Primary Device ID03700512922056
NIH Device Record Key103592be-5a69-4723-becd-d24daa30ea10
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrology TURP 2 Spike
Version Model NumberRF2TURP
Catalog NumberSOUR9201ST12
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
GS103700512902058 [Primary]
GS103700512912057 [Package]
Contains: 03700512902058
Package: Box Label 1 [10 Units]
In Commercial Distribution
GS103700512922056 [Package]
Contains: 03700512912057
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

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03700512987475 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire2024-01-15
03700512987482 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.28cm, without wire2024-01-15
03700512987499 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.30cm, without wire2024-01-15
03700512987505 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire2024-01-15
03700512977513 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire2024-01-15

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