DEVICE: NA (10886982129543)
Device Identifier (DI) Information
NA
05.001.180
In Commercial Distribution
05001180
Synthes GmbH
05.001.180
In Commercial Distribution
05001180
Synthes GmbH
IRRIGATION NOZZLE F/PEN DRIVE F/PERFORATOR W/HUDSON COUPLING
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 47886 | Surgical power tool irrigation-control device |
A device designed to be activated by the surgeon to regulate the flow of irrigation fluid (normally sterile saline) to the surgical site where a rotational high-speed cutting tool [e.g., 40.000 - 90.000 revolutions per minute (rpm)] is being applied to bone; primarily to provide the fluid as a coolant to the cutting tool (e.g., a bur or drill bit) and the site to avoid necrosis. It typically consists of tubing, connectors, and a simple electrically or pneumatically activated valve in which the coolant tubing is placed and which is pinched to regulate the fluid flow. It is typically made of metal and/or synthetic materials. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| DZI | DRILL, BONE, POWERED |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K043310 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
620ede18-3e1e-49b7-ac51-8fd87f045ff5
April 18, 2022
5
June 30, 2016
April 18, 2022
5
June 30, 2016
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 |
|---|---|
| HIBCC | H679050011800 |
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(800)255-2500
xx@xx.xx
xx@xx.xx