Endo-Block Ruler - 1 unit. - NUSMILE, LTD.

Duns Number:185497372

Device Description: 1 unit.

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More Product Details

Catalog Number

-

Brand Name

Endo-Block Ruler

Version/Model Number

ZEB

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)

-

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

EIL

Product Code Name

Gauge, Depth, Instrument, Dental

Device Record Status

Public Device Record Key

2ab0771c-f69a-4455-a76e-a8ea95f124de

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUSMILE, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1091
2 A medical device with a moderate to high risk that requires special controls. 16
U Unclassified 1