Duns Number:119193803
Device Description: Tired of the inconvenience and expense of saliva ejector valve tips that pull off during a Tired of the inconvenience and expense of saliva ejector valve tips that pull off during a procedure or get lost? Upgrade to our Lock-On Saliva Ejector Valve Tips. For no more than the cost of regular silicone SE tips, Lock-Ons fit your existing valves and stay put under tension. Installing them takes only a few seconds. Tips fit all standard saliva ejector valves and adapters. Bright blue color identifies them at a glance. Silicone and Viton® ring construction is fully sterilizable up to 375°F. Three blue tips and six locking rings per pack.
Catalog Number
70-39775
Brand Name
Lock-On Saliva Ejector Valve Tips
Version/Model Number
70-39775
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"
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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
EHZ
Product Code Name
Evacuator, Oral Cavity
Public Device Record Key
37716d13-f10b-409a-b68d-13beb1d37da5
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |