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

GUDID 03700512911067

Promepla

Surgical irrigation/aspiration tubing set

• Primary Device ID: 03700512911067
• NIH Device Record Key: c6d8a7a3-cd6a-4b04-9569-90ae89db3a0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laparoscopy - 1 Way High Flow Irrigation/Aspiration set + Handpiece & probe (Æ
• Version Model Number: SOLA1033ST12
• Catalog Number: SOLA1033ST12
• Company DUNS: 401020409
• Company Name: Promepla
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +37797984232
• Email: customer@rocamed.eu

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512901068 [Primary]
GS1	03700512911067 [Package]; Contains: 03700512901068; Package: Box Label [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152278

FDA Product Code

• FHF: System, Evacuator, Fluid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-10-11

Devices Manufactured by Promepla

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• 03700512987468 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire: 2024-01-15
• 03700512987475 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire: 2024-01-15
• 03700512987482 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.28cm, without wire: 2024-01-15
• 03700512987499 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.30cm, without wire: 2024-01-15
• 03700512987505 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire: 2024-01-15
• 03700512977513 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire: 2024-01-15