Norland at Swissray

GUDID 04719882151019

LELTEK INC.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID04719882151019
NIH Device Record Keye1e653a0-8455-4d5d-915b-55890d7e5b34
Commercial Distribution StatusIn Commercial Distribution
Brand NameNorland at Swissray
Version Model NumberLU700C
Company DUNS656116467
Company NameLELTEK 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719882151019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


[04719882151019]

Chlorine Dioxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-04
Device Publish Date2021-01-27

On-Brand Devices [Norland at Swissray]

04719882151026LU700L
04719882151019LU700C

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