Z-Rinse 30GA 22mm - 50 units - NUSMILE, LTD.

Duns Number:185497372

Device Description: 50 units

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More Product Details

Catalog Number

-

Brand Name

Z-Rinse 30GA 22mm

Version/Model Number

UDIN3022050

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)

-

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

86a35370-2d71-4a5d-9d5f-628a374ed11f

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUSMILE, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1091
2 A medical device with a moderate to high risk that requires special controls. 16
U Unclassified 1