Expasyl cannulas - Expasyl straight application cannulas x40 for - PRODUITS DENTAIRES PIERRE ROLLAN

Duns Number:277657631

Device Description: Expasyl straight application cannulas x40 for EXPASYL paste (sulcular opening paste).

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More Product Details

Catalog Number

261040

Brand Name

Expasyl cannulas

Version/Model Number

EXPASYL

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K050180,K050180

Product Code Details

Product Code

MVL

Product Code Name

Cord, Retraction

Device Record Status

Public Device Record Key

a88ecc8c-e9b1-4a6c-a7e2-a65830aee328

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRODUITS DENTAIRES PIERRE ROLLAN" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 7