Primary Device ID | 07350096320043 |
NIH Device Record Key | 257322a2-919f-4e21-b01e-a3dcbc7e7b2f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Penguin RFA |
Version Model Number | Penguin RFA Instrument Kit Klockner White |
Catalog Number | 55002-KW |
Company DUNS | 352736781 |
Company Name | Integration Diagnostics Sweden AB |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Serial Number | true |
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 Issuing Agency | Device ID |
---|---|
GS1 | 07350096320043 [Direct Marking] |
GS1 | 07350096320135 [Primary] |
EKX | Handpiece, Direct Drive, Ac-Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-16 |
Device Publish Date | 2022-03-08 |
07350096320029 | Penguin RFA Instrument Kit Neoss |
07350096320036 | Penguin RFA Instrument Kit Implant Swiss |
07350096320012 | Penguin RFA Instrument Kit |
07350096320388 | Penguin RFA Instrument Kit OsseoFuse |
07350096320296 | Penguin RFA Instrument Kit SIC |
07350096320203 | IS3 Instrument Kit |
07350096320197 | Penguin RFA Instrument Kit Bredent |
07350096320067 | Penguin RFA Instrument Kit Citagenix |
07350096320050 | Penguin RFA Instrument Kit Klockner Black |
07350096320043 | Penguin RFA Instrument Kit Klockner White |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PENGUIN RFA 88009146 5909358 Live/Registered |
Integration Diagnostics Sweden AB 2018-06-21 |