Laparoscopy - 1 Way High Flow Irrigation/Aspiration set + Handpiece & probe (Æ SOLA1033ST12

GUDID 03700512911067

Promepla

Surgical irrigation/aspiration tubing set
Primary Device ID03700512911067
NIH Device Record Keyc6d8a7a3-cd6a-4b04-9569-90ae89db3a0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaparoscopy - 1 Way High Flow Irrigation/Aspiration set + Handpiece & probe (Æ
Version Model NumberSOLA1033ST12
Catalog NumberSOLA1033ST12
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

Customer Support Contacts

Phone+37797984232
Emailcustomer@rocamed.eu

Device Identifiers

Device Issuing AgencyDevice ID
GS103700512901068 [Primary]
GS103700512911067 [Package]
Contains: 03700512901068
Package: Box Label [5 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 Number6
Public Version Date2019-11-11
Device Publish Date2016-10-11

Devices Manufactured by Promepla

03700512925064 - Irrigation Tube2024-11-01
03700512925071 - Irrigation Tube2024-11-01
03700512915263 - Irrigation Tube2024-11-01
03700512921967 - Y-CLIC ADAPTER2024-01-15
03700512987451 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire2024-01-15
03700512987468 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire2024-01-15
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

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