Endoch - DISPOSABLE BIOPSY FORCEPS, WITH SPIKE, NON-COATED - Endoch Inc

Duns Number:241382683

Device Description: DISPOSABLE BIOPSY FORCEPS, WITH SPIKE, NON-COATED

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More Product Details

Catalog Number

DBF-2323RS

Brand Name

Endoch

Version/Model Number

DBF-2323RS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

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

FCL

Product Code Name

Forceps, Biopsy, Non-Electric

Device Record Status

Public Device Record Key

1b2befba-99ce-4558-a519-68c13afe9d2d

Public Version Date

June 10, 2019

Public Version Number

1

DI Record Publish Date

June 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENDOCH INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 325
2 A medical device with a moderate to high risk that requires special controls. 30