Surgical Instrument - Jeil Medical Corporation

Duns Number:688811603

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Surgical Instrument

Version/Model Number

114-009

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

-

Product Code Details

Product Code

HTD

Product Code Name

Forceps

Device Record Status

Public Device Record Key

a072bec3-8f06-48ca-8659-c1b53d52c412

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JEIL MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1292
2 A medical device with a moderate to high risk that requires special controls. 6497