N/A - Tissue Protector for Drill 3.5 and Over-Drill 3.5 - Merete GmbH

Duns Number:313267265

Device Description: Tissue Protector for Drill 3.5 and Over-Drill 3.5 color-coated green non-sterile

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

CH15040

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"

-

For Single-Use

-

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

FZX

Product Code Name

Guide, surgical, instrument

Device Record Status

Public Device Record Key

d3275e94-31ed-4f04-837a-93ec6e809d36

Public Version Date

October 20, 2022

Public Version Number

2

DI Record Publish Date

November 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERETE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 1327
U Unclassified 13