Catalog Number

-

Brand Name

LLETZ Braun Tenaculum

Version/Model Number

LT2250

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K980247

Product Code

HDC

Product Code Name

Tenaculum, Uterine

Public Device Record Key

f2226099-6eb2-4cf6-8e84-c50f0565a7bd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-