POTENZA Tip

GUDID 18800020101188

I-16 Tip (FDA/1EA)

Jeisys Medical Inc.

Electrosurgical system

• Primary Device ID: 18800020101188
• NIH Device Record Key: 7febe235-2f48-42a3-ab7a-7fbde81511da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POTENZA Tip
• Version Model Number: I-16 Tip
• 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	08800020101181 [Primary]
GS1	18800020101188 [Package]; Contains: 08800020101181; 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)