CEKA & PRECI-LINE ATTACHMENTS - CEKA M3 IR - Alphadent NV

Duns Number:283174985

Device Description: CEKA M3 IR

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More Product Details

Catalog Number

OL 334

Brand Name

CEKA & PRECI-LINE ATTACHMENTS

Version/Model Number

OL 334

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

EGG

Product Code Name

ATTACHMENT, PRECISION, ALL

Device Record Status

Public Device Record Key

723a1d10-cd20-4a72-afe4-310ed5eb6fe4

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHADENT NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 346
2 A medical device with a moderate to high risk that requires special controls. 7