DEVICE: N/A (00885825013301)
Device Identifier (DI) Information
N/A
N/A
In Commercial Distribution
5DCD
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
In Commercial Distribution
5DCD
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Endopath Curved Dissector w/Unipolar Cautery
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61815 | Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed |
A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, probe with controls) and requires a patient contact return electrode to complete the circuit. This is a previously used single-use device that has been processed for an additional single-use patient application.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NUJ | ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED |
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 -22 and 60 Degrees Celsius |
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Diameter: 5.0 Millimeter |
Device Record Status
fa239f32-f2fa-4dcd-a37c-c89cf6e28436
February 14, 2020
3
September 23, 2016
February 14, 2020
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 |
---|---|---|---|---|---|
30885825013302 | 6 | 00885825013301 | 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(888)888-3433
RegulatoryAffairs2@stryker.com
RegulatoryAffairs2@stryker.com