1.2ml Plastic Syringe - Hemostatic Delivery Syringe 20pk 1.2ml - ULTRADENT PRODUCTS, INC.

Duns Number:013369913

Device Description: Hemostatic Delivery Syringe 20pk 1.2ml

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More Product Details

Catalog Number

1278

Brand Name

1.2ml Plastic Syringe

Version/Model Number

1278

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

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

EIC

Product Code Name

SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Device Record Status

Public Device Record Key

9eb32c99-a077-476a-905a-7a0ed799e63c

Public Version Date

April 18, 2022

Public Version Number

1

DI Record Publish Date

April 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ULTRADENT PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 450
2 A medical device with a moderate to high risk that requires special controls. 631
U Unclassified 18