ELMED - 5MM, 45CM, CLEAR FLUSH, FENESTRATED DOUBLE FUNDUS - ELMED INCORPORATED

Duns Number:049290364

Device Description: 5MM, 45CM, CLEAR FLUSH, FENESTRATED DOUBLE FUNDUS GRASPER, RADEL INSULATION, RIGID, ONE PI 5MM, 45CM, CLEAR FLUSH, FENESTRATED DOUBLE FUNDUS GRASPER, RADEL INSULATION, RIGID, ONE PIECE

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More Product Details

Catalog Number

5-0545-226A

Brand Name

ELMED

Version/Model Number

5-0545-226A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181173

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

fd643bcd-b6ed-4db5-bfbe-1f8f3372adaf

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELMED INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 4068