Monolith Syringe - PRISMAN INC.

Duns Number:117569946

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More Product Details

Catalog Number

-

Brand Name

Monolith Syringe

Version/Model Number

M527

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)

-

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

EID

Product Code Name

Syringe, Restorative And Impression Material

Device Record Status

Public Device Record Key

91501c47-5e99-4a5b-8123-9ba62fa1d317

Public Version Date

November 10, 2021

Public Version Number

1

DI Record Publish Date

November 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRISMAN INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29