DEVICE: NA (04546540184719)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Surgical irrigation handpiece nozzle | A sterile device designed to be attached to the distal end of a lavage system or kit handpiece to function as an applicator/nozzle that produces an intentional jet, stream or spray of sterile fluid (typically saline) from its aperture to the site of operation during a surgical intervention (e.g., trauma, soft tissue application and orthopaedic) for the purpose of removing tissue, bone debridement and/or bone cement residue, and to clean the site. It is available in many designs, shapes and sizes, including a fan spray, shower spray, high capacity with multiple aperture spray; some have a built-in filter, splash shield, or brush. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FQH | LAVAGE, JET |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d41fb924-dbcc-4a4f-87db-7dde18009e68
February 21, 2019
3
September 23, 2016
February 21, 2019
3
September 23, 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 |
---|---|---|---|---|---|
34546540184710 | 12 | 04546540184719 | In Commercial Distribution | pack |
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(800)253-3210
Inst.Stryker.cs@Stryker.com
Inst.Stryker.cs@Stryker.com