OlyPercX PCNL Basket RFPERKX

GUDID 03700512968191

for Rocamed Laser fiber max 272µm

Promepla

Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use

• Primary Device ID: 03700512968191
• NIH Device Record Key: 47867af5-6767-4924-8c46-0b1733094b9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OlyPercX PCNL Basket
• Version Model Number: ROKP1001ST245
• Catalog Number: RFPERKX
• Company DUNS: 401020409
• Company Name: Promepla
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512968191 [Primary]
GS1	03700512978190 [Package]; Package: Box 1 [1 Units]; In Commercial Distribution
GS1	03700512988199 [Package]; Contains: 03700512978190; Package: Box 2 [5 Units]; In Commercial Distribution

FDA Product Code

• FFL: Dislodger, Stone, Basket, Ureteral, Metal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-04
• Device Publish Date: 2020-08-27

Devices Manufactured by Promepla

• 03700512921967 - Y-CLIC ADAPTER: 2024-01-15
• 03700512987451 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire: 2024-01-15
• 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