PURE DentA ND_PRD00480-00

GUDID 07290016814668

The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures.

ENDYMED MEDICAL LTD

Multi-modality skin contouring system
Primary Device ID07290016814668
NIH Device Record Keyb20eabaf-f2d0-4391-b210-703139f7201e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePURE DentA
Version Model NumberPURE DentA 110V
Catalog NumberND_PRD00480-00
Company DUNS531958689
Company NameENDYMED MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-14
Device Publish Date2024-11-06

Devices Manufactured by ENDYMED MEDICAL LTD

07290016814668 - PURE DentA2024-11-14The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures.
07290016814668 - PURE DentA2024-11-14 The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures.
07290016814408 - EndyMed PRO MAX, System, 110V2024-05-24 The EndyMed PRO MAX System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-
07290016814415 - endyMed PRO MAX, Intensif MAX Handpiece2024-05-24 The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis
07290016814422 - EndyMed PRO MAX, Small MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814439 - EndyMed PRO MAX, FSR MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814446 - EndyMed PRO MAX, iFine MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814453 - EndyMed PRO MAX,Shaper MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814460 - EndyMed PRO MAX,Mini Shaper MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologi
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