Obtura Spartan - Tip Set of 8 PST 1-8Contains:941-101 Tip PST-1 - OBTURA SPARTAN ENDODONTICS

Duns Number:078371330

Device Description: Tip Set of 8 PST 1-8Contains:941-101 Tip PST-1 DI# 00816168020565941-102 Tip PST-2 DI# 008 Tip Set of 8 PST 1-8Contains:941-101 Tip PST-1 DI# 00816168020565941-102 Tip PST-2 DI# 00816168020572941-103 Tip PST-3 DI# 00816168020589941-104 Tip PST-4 DI# 00816168020596941-105 Tip PST-5 DI# 00816168020602941-106 Tip PST-6 DI# 00816168020619941-107 Tip PST-7 DI# 00816168020626941-108 Tip PST-8 DI# 00816168020633

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More Product Details

Catalog Number

941-109

Brand Name

Obtura Spartan

Version/Model Number

941-109

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

ELC

Product Code Name

Scaler, Ultrasonic

Device Record Status

Public Device Record Key

e437cfa0-3e39-4a27-9154-ca895705ec4e

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OBTURA SPARTAN ENDODONTICS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 74