PARALLELOMETER - PARALLELOMETER INSERT PREMIUM ONE - SWEDEN & MARTINA SPA

Duns Number:433815198

Device Description: PARALLELOMETER INSERT PREMIUM ONE

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More Product Details

Catalog Number

PAR-INS-AS

Brand Name

PARALLELOMETER

Version/Model Number

PAR-INS-AS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

c8c244df-3d4e-490c-8cae-dd318121012e

Public Version Date

January 18, 2022

Public Version Number

1

DI Record Publish Date

January 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SWEDEN & MARTINA SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1248
2 A medical device with a moderate to high risk that requires special controls. 1062