DEVICE: Uni-Tip -Package of 25 (D248B16351)
Device Identifier (DI) Information
Uni-Tip -Package of 25
B1635
In Commercial Distribution
HAGER WORLDWIDE, INC.
B1635
In Commercial Distribution
HAGER WORLDWIDE, INC.
Chrome-plated air/water syringe
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
65430 | Dental delivery system irrigation handpiece tip |
A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ECB | UNIT, SYRINGE, AIR AND/OR WATER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
20566372-34e6-4bc4-944f-c3cf05e96fa4
September 20, 2023
1
September 12, 2023
September 20, 2023
1
September 12, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(828)624-3319
d.pritchard@hagerworldwide.com
d.pritchard@hagerworldwide.com