NA - The Carr-Locke injection needle is a single use, - US Endoscopy

Duns Number:627879687

Device Description: The Carr-Locke injection needle is a single use, disposable, flexible sheath injection nee The Carr-Locke injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.

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More Product Details

Catalog Number

00711812

Brand Name

NA

Version/Model Number

00711812

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"

Yes

For Single-Use

Yes

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

FCG

Product Code Name

Biopsy needle

Device Record Status

Public Device Record Key

78fdd5ba-991b-421f-a165-5cc9137c9dd6

Public Version Date

November 10, 2020

Public Version Number

2

DI Record Publish Date

April 02, 2020

Additional Identifiers

Package DI Number

10724995180895

Quantity per Package

5

Contains DI Package

00724995180898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"US ENDOSCOPY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 902