ELMED INCORPORATED ST5250517

GUDID 00198506040009

5mm,34cm, Retractor/Elevator with 5 Flat Blades-55mm Spreadable and 60 deg. Articulating, Round Handle w/ front and rear adjustment , Knobs and flushport.

ELMED INCORPORATED

Laparoscopic surgical procedure kit, non-medicated, reusable
Primary Device ID00198506040009
NIH Device Record Keya95db29b-c1ab-4d97-b367-38288464e743
Commercial Distribution StatusIn Commercial Distribution
Brand NameELMED INCORPORATED
Version Model NumberST5250517
Catalog NumberST5250517
Company DUNS049290364
Company NameELMED INCORPORATED
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100198506040009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

[00198506040009]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-27
Device Publish Date2024-09-19

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