Duns Number:078371330
Device Description: Tip Set of 6 BUC AccessContains:930-041 Tip BUC-1 DI# 00816168020299930-042 Tip BUC-2 DI# Tip Set of 6 BUC AccessContains:930-041 Tip BUC-1 DI# 00816168020299930-042 Tip BUC-2 DI# 00816168020305930-043 Tip BUC-3 DI# 00816168020312930-046 Tip BUC-2A DI# 00816168020510930-048 Tip BUC-1A DI# 00816168020534930-049 Tip BUC-3A DI# 00816168020541
Catalog Number
930-050
Brand Name
Obtura Spartan
Version/Model Number
930-050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
35fba2ad-1b33-4ba9-8689-ccad4117f55c
Public Version Date
September 27, 2022
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 74 |