OSE - POSI-Lock™ Light Cure Flowable Composite Syringe - ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC

Duns Number:077801124

Device Description: POSI-Lock™ Light Cure Flowable Composite Syringe

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More Product Details

Catalog Number

-

Brand Name

OSE

Version/Model Number

0167-RC

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

-

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

f9bbf3c9-fbec-4395-b32d-29b281badc56

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 389
2 A medical device with a moderate to high risk that requires special controls. 10