Device
Single use Tips that are used with the Intensif / Intensif MAX handpiece
Manufacturer
ENDYMED MEDICAL LTD
Model: Intensif 10 pack tips package (JOYMED) Catalog: ND_PRD00177 DI: 07290016814675 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Description
Single use Tips that are used with the Intensif / Intensif MAX handpiece
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: d9d607b1-f3ba-45ea-b144-1bb7d764f97c
Distribution Status: In Commercial Distribution
DUNS Number: 531958689
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 07290016814675
Type: Primary
Issuing Agency: GS1
GMDN
Code: 61222
Name: Cosmetic micro-needling electronic handpiece cartridge, professional
Definition:
A device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use device.
FDA Product Codes
OUH
Skin Resurfacing Rf Applicator
GEI
Electrosurgical, Cutting & Coagulation & Accessories