EL400

GUDID 04560224986819

NAKANISHI INC.

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Primary Device ID04560224986819
NIH Device Record Key082ac0b5-9361-4cac-8d95-d9829b604434
Commercial Distribution StatusIn Commercial Distribution
Brand NameEL400
Version Model NumberEL400 CD
Company DUNS690710546
Company NameNAKANISHI INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS104560224986819 [Primary]

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-14
Device Publish Date2020-12-05

Devices Manufactured by NAKANISHI INC.

04560264500730 - Primado22024-04-03
04560264500747 - Primado22024-04-03
04560264511668 - Primado22024-04-03
04560264511675 - Primado22024-04-03
04560264511705 - Primado22024-04-03
04560264511736 - Primado22024-04-03
04560264523081 - Primado22024-04-03
04560264523098 - Primado22024-04-03

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