Singnature Series

GUDID 08714729516699

Electrosurgical Devices, Cutting Loop

PROSURG INC

Electrosurgical system

• Primary Device ID: 08714729516699
• NIH Device Record Key: 5b7193fc-bc34-4402-add4-a2228c2d6d1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Singnature Series
• Version Model Number: M0068802490
• Company DUNS: 188684609
• Company Name: PROSURG INC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French
• Catheter Gauge: 28 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729516699 [Package]; Contains: 08714729890133; Package: [10 Units]; In Commercial Distribution
GS1	08714729890133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962593

FDA Product Code

• FAS: Electrode, Electrosurgical, Active, Urological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-04
• Device Publish Date: 2016-09-23

Devices Manufactured by PROSURG INC

• 10851545007712 - Prosurg: 2023-11-17 Neo-Arthroscope 4.0 mm (30 Degrees)
• 10851545007729 - Prosurg: 2023-11-17 Neo-Arthroscope 1.8 mm (0 Degrees)
• 10851545007811 - Prosurg: 2023-11-17 Neo-Arthroscope 2.3 mm (15 Degrees)
• 10851545007187 - Prosurg: 2023-04-04 5mm Roller Ball 24 Fr Storz Double Stem
• 10851545007309 - Prosurg: 2023-04-04 Salinetrode Cutting Loop 24 FR Double Stem
• 10851545007330 - Prosurg: 2023-04-04 Salinetrode Cutting Loop 24 FR
• 10851545007354 - Prosurg: 2023-04-04 Salinetrode Cutting Loop 24 Wolf
• 10851545007422 - Prosurg: 2023-04-04 Salinetrode Flex 5.0 Fr 40 cm