DEVICE: N/A (00885825014315)
Device Identifier (DI) Information
N/A
N/A
In Commercial Distribution
ASC4250-01
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
In Commercial Distribution
ASC4250-01
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Soft Tissue Ablator 90 w/Integrated Cable
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? |
---|---|---|---|---|
61951 | Endoscopic electrosurgical electrode, bipolar, reprocessed |
A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps) which may include a lumen for suction/irrigation; it does not include a handpiece/housing with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). 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 [?] |
---|---|
K043198 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Degree: 90.0 Degree |
Device Record Status
68028555-6310-4d52-b09d-ffaff7f469fc
February 14, 2020
4
September 23, 2016
February 14, 2020
4
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 |
---|---|---|---|---|---|
30885825014316 | 4 | 00885825014315 | 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