Catalog Number

-

Brand Name

Thermo Bolus 20x20x0,5cm – non perforated (5pcs)

Version/Model Number

P10107-651

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 11, 2022

Issuing Agency

In GS1

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

K081218

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

af7f9d20-957f-447e-a0a5-c6a841b5763b

Public Version Date

February 14, 2022

Public Version Number

7

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-