Duns Number:008124539
Device Description: Bulb Irrigation Syringe with Protective Cap Tubing Adaptor, Sterile, 60cc
Catalog Number
-
Brand Name
Bulb Irrigation Syringe
Version/Model Number
4261
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
Yes
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
KYZ
Product Code Name
Syringe, Irrigating (Non Dental)
Public Device Record Key
9e78abb8-aba7-43c9-8f8a-86a5062984b5
Public Version Date
May 10, 2022
Public Version Number
1
DI Record Publish Date
May 02, 2022
Package DI Number
00616784426136
Quantity per Package
50
Contains DI Package
00616784426112
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |