BioCeps Biopsy Forceps - Endoscopic Biopsy Forceps with Needle - Hot - ENDO-THERAPEUTICS, INC.

Duns Number:825239189

Device Description: Endoscopic Biopsy Forceps with Needle - Hot

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More Product Details

Catalog Number

ET1403

Brand Name

BioCeps Biopsy Forceps

Version/Model Number

ET1403

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

K800973,K800973

Product Code Details

Product Code

KNS

Product Code Name

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Device Record Status

Public Device Record Key

1290d943-451f-425d-960b-07a43f4e1726

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Additional Identifiers

Package DI Number

10816207021437

Quantity per Package

10

Contains DI Package

00816207021430

Package Discontinue Date

-

Package Status

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