Duns Number:078371330
Device Description: EMS Threaded Tip Set of 4 BUCContains:932-018 Tip BUC-1E DI# 00816168020480932-019 Tip BUC EMS Threaded Tip Set of 4 BUCContains:932-018 Tip BUC-1E DI# 00816168020480932-019 Tip BUC-2E DI# 00816168020497932-020 Tip BUC-3E DI# 00816168020503
Catalog Number
932-024
Brand Name
Obtura Spartan
Version/Model Number
932-024
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
7a583e23-4652-4ede-8f0b-b597b991ca9f
Public Version Date
September 27, 2022
Public Version Number
4
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 |