BioCeps Biopsy Forceps, Esophageal - Biopsy Forceps, Uncoated, Cold - ENDO-THERAPEUTICS, INC.

Duns Number:825239189

Device Description: Biopsy Forceps, Uncoated, Cold

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More Product Details

Catalog Number

ET1442

Brand Name

BioCeps Biopsy Forceps, Esophageal

Version/Model Number

ET1442

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

FCL

Product Code Name

Forceps, Biopsy, Non-Electric

Device Record Status

Public Device Record Key

80ea7018-9b76-4a6b-a0a6-07a54eec2707

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Additional Identifiers

Package DI Number

10816207021567

Quantity per Package

10

Contains DI Package

00816207021560

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