DEVICE: GEN2 (00840343715526)
Device Identifier (DI) Information
GEN2
G2E30010
In Commercial Distribution
G2E30010
SURGIX MEDICAL LLC
G2E30010
In Commercial Distribution
G2E30010
SURGIX MEDICAL LLC
AUSTIN DUCKBILL ELEVATOR, SLIGHT CVD BLADE, 2.2MM WIDE, 6-1/4"
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? |
---|---|---|---|---|
35048 | Bone lever/elevator, reusable |
A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEG | Elevator, Surgical, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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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Length: 6.25 Inch |
Device Size Text, specify: Tip length 2.2mm |
Device Record Status
70331b5a-50a9-4247-84eb-c07782a7e1e9
January 23, 2023
1
January 13, 2023
January 23, 2023
1
January 13, 2023
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 |
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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
[?]
888-247-0477
customerservice@surgixmedical.com
customerservice@surgixmedical.com