Duns Number:078371330
Device Description: EMS Threaded Tip Set CPR 1-5EContains:932-001 Tip CPR-1E DI# 00816168020329932-002 Tip CPR EMS Threaded Tip Set CPR 1-5EContains:932-001 Tip CPR-1E DI# 00816168020329932-002 Tip CPR-2E DI# 00816168020336932-003 Tip CPR-3E DI# 00816168020343932-004 Tip CPR-4E DI# 00816168020350932-005 Tip CPR-5E DI# 00816168020367
Catalog Number
932-009
Brand Name
Obtura Spartan
Version/Model Number
932-009
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
15e3286c-984b-4a17-bdc4-92277d277934
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 |