ENDODONTIC POSTS - DISPOSABLE titanium device with low profile head - RHEIN 83 SRL

Duns Number:439240722

Device Description: DISPOSABLE titanium device with low profile head to be cemented into the root canal

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More Product Details

Catalog Number

333PEK10

Brand Name

ENDODONTIC POSTS

Version/Model Number

PIVOT tit. EQUATOR mm.10 set

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

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

ELR

Product Code Name

Post, Root Canal

Device Record Status

Public Device Record Key

fbace85f-ddf2-41db-892f-3ab9fe7f4c97

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RHEIN 83 SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1269
2 A medical device with a moderate to high risk that requires special controls. 1987