PELLEFIRM Handpiece P325PFHPU

GUDID 00841494105280

PELLEFIRM RF HP, 25MM USA (BOX OF 3)

Ellman International

Electrosurgical system

• Primary Device ID: 00841494105280
• NIH Device Record Key: e295ec80-0a33-42e4-926b-e6dc649fccd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PELLEFIRM Handpiece
• Version Model Number: P325PFHPU
• Catalog Number: P325PFHPU
• Company DUNS: 079095245
• Company Name: Ellman International
• Device Count: 3
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00841494105280 [Primary]
GS1	10841494105287 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132949

FDA Product Code

• PBX: Massager, vacuum, radio frequency induced heat

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [PELLEFIRM Handpiece]

• 00841494105297: PELLEFIRM RF HP, 30MM USA (BOX OF 3)
• 00841494105280: PELLEFIRM RF HP, 25MM USA (BOX OF 3)
• 00841494105112: PELLEFIRM VARI-PAK USA 2 HP & 2 HEADS