Biopsy Forceps - Endoscopic Biopsy Forceps - ENDO-THERAPEUTICS, INC.

Duns Number:825239189

Device Description: Endoscopic Biopsy Forceps

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More Product Details

Catalog Number

SG-111-612

Brand Name

Biopsy Forceps

Version/Model Number

SG-111-612

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2019

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

FCL

Product Code Name

Forceps, Biopsy, Non-Electric

Device Record Status

Public Device Record Key

4843b0f1-9946-44e9-be16-fb44b7d1bc9c

Public Version Date

November 05, 2019

Public Version Number

2

DI Record Publish Date

May 14, 2018

Additional Identifiers

Package DI Number

10816207020720

Quantity per Package

10

Contains DI Package

00816207020723

Package Discontinue Date

November 04, 2019

Package Status

Not in Commercial Distribution

Package Type

Box

"ENDO-THERAPEUTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 85