DEVICE: Greenwald Surgical Company, Inc. (10801334012663)
Device Identifier (DI) Information
Greenwald Surgical Company, Inc.
71002-01
In Commercial Distribution
1024
GRACE MANUFACTURING, INC.
71002-01
In Commercial Distribution
1024
GRACE MANUFACTURING, INC.
BOVIE BUSHING (82707 for 1024)
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? |
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58068 | Electrosurgical/ultrasonic surgical system tester interface |
A non-sterile electrical connecting device designed to provide an interface between a commonly used electrical output analyser/equipment and an electrosurgical system generator and an ultrasonic surgical system generator, or a combination electrosurgical/ultrasonic surgical system generator when being tested for power output in a non-clinical setting. Commonly known as a verification key, it is typically used by a hospital clinical engineer when testing the generators during routine maintenance or inspection and provides standard connector components (e.g., banana plug receptacles) to allow simpler interface with a custom generator connector. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HGI | Electrocautery, Gynecologic (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Ethylene Oxide |
Liquid Chemical |
Moist Heat or Steam Sterilization |
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
961945f2-a26a-470d-b48d-4602b9781acd
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined