POTENZA Tip

GUDID 18800020101140

A1-15 (FDA/1EA)

Jeisys Medical Inc.

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 18800020101140
• NIH Device Record Key: 6d76ecba-98cc-4b46-bf7d-1b4cfebeed0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POTENZA Tip
• Version Model Number: A1-15
• Company DUNS: 690275362
• Company Name: Jeisys Medical 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08800020101143 [Primary]
GS1	18800020101140 [Package]; Contains: 08800020101143; Package: CARTON BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201685

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2022-04-06
• Device Publish Date: 2022-03-29

On-Brand Devices [POTENZA Tip]

• 08800020111272: POTENZA Tip (Sterile micro needle electrode A1-15 Tip)
• 08800020111265: POTENZA Tip (Sterile micro needle electrode A1-12 Tip)
• 08800020111258: POTENZA Tip (Sterile micro needle electrode P1-08 Tip)
• 08800020111159: POTENZA Tip (Sterile micro needle electrode S-16 tip)
• 08800020111142: POTENZA Tip (Sterile micro needle electrode I-16 Tip)
• 08800020111135: POTENZA Tip (Sterile micro needle electrode S-25 Tip)
• 08800020111128: POTENZA Tip (Sterile micro needle electrode I-25 Tip)
• 08800020111111: POTENZA Tip (Sterile micro needle electrode S-49 Tip)
• 08800020111104: POTENZA Tip (Sterile micro needle electrode I-49 Tip)
• 08800020100191: POTENZA Tip (Sterile micro needle electrode CP-21 Tip)
• 08800020100207: POTENZA Tip (Sterile micro needle electrode Combo-box)
• 08800020100269: POTENZA Tip (Sterile micro needle electrode S-25 Tip / 1EA)
• 08800020100252: POTENZA Tip (Sterile micro needle electrode I-25 Tip / 1EA)
• 08800020100245: POTENZA Tip (Sterile micro needle electrode S-49 Tip / 1EA)
• 08800020100238: POTENZA Tip (Sterile micro needle electrode I-49 Tip / 1EA)
• 08800020100221: POTENZA Tip (Sterile micro needle electrode CP-21 Tip / 1EA)
• 18800020101201: P1-08 (FDA/1EA)
• 18800020101195: S-16 Tip (FDA/1EA)
• 18800020101188: I-16 Tip (FDA/1EA)
• 18800020101171: C9 Tip (FDA/1EA)
• 18800020101164: C21-2 Tip (FDA/1EA)
• 18800020101157: C21-1 Tip (FDA/1EA)
• 18800020101140: A1-15 (FDA/1EA)
• 18800020101133: A1-12 (FDA/1EA)