DENTAL EQUIPMENTS - DISPOSABLE device used to contain the retentive - RHEIN 83 SRL

Duns Number:439240722

Device Description: DISPOSABLE device used to contain the retentive cap inside the removable prosthesis.

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More Product Details

Catalog Number

CN002-100

Brand Name

DENTAL EQUIPMENTS

Version/Model Number

CLEAR CAPS STANDARD size 100u.

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

4b97ff08-345a-4081-ae11-b4efafb3a0c7

Public Version Date

July 23, 2021

Public Version Number

1

DI Record Publish Date

July 15, 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