Primary Device ID | 00810000520770 |
NIH Device Record Key | 519aee67-e02d-41e2-b693-643d9eaf3d8d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sensimatic™ |
Version Model Number | D703 |
Catalog Number | D703 |
Company DUNS | 009900424 |
Company Name | PARKELL, 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 | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
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 |
Phone | 6312491134 |
customerservice@parkell.com | |
Phone | 6312491134 |
customerservice@parkell.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810000520770 [Primary] |
EKZ | Unit, Electrosurgical, And Accessories, Dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-09-18 |
Device Publish Date | 2018-09-21 |
00810000520770 | Indifferent Plate and Cable for SSensimatic® 700SE |
00810000520763 | Electrode Handpiece and Cable for Sensimatic® 700SE |
00810000520756 | D700SE Sensimatic™ Electrosurge 230volts |
M595D6330 | Black Handpiece and Cable for Sensimatic® Electrosurge |
M595D633CK0 | Locking Chuck (only) for Sensimatic™ Handpiece |
M595D700SE1100 | D700SE Sensimatic™ Electrosurge 110v |
M595D6340 | Indifferent Plate for Sensimatic™ Electrosurge |
M595D6010 | New Indifferent Plate & Red Cable for Sensimatic™ 600SE (Complies with New FDA Lead Wire Regul |
00810000520107 | Indifferent Plate and Cable for Sensimatic® 700SE (Korea) |
M595D700SE10CR0 | Certified Refurbish 700SE Sensimatic™ Electrosurge 110 Volt |
M595D600SE1100 | D600SE Sensimatic™ Electrosurge 110 Volt |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SENSIMATIC 87217477 5214026 Live/Registered |
Parkell, Inc. 2016-10-27 |