DEVICE: Gen2 (00840343700386)

Device Identifier (DI) Information

Gen2
G2E17507
In Commercial Distribution
G2E17507
SURGIX MEDICAL LLC
00840343700386
GS1

1
080402644 *Terms of Use
G277G2E175070
HOUSE ELEVATOR 'GIMMICK' ANG 1
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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?
38168 Periosteal elevator, reusable
A hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEG Elevator, Surgical, General & Plastic Surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Blade Length 12 mm
Device Size Text, specify: Blade width 1 mm
Device Size Text, specify: Angle 15 degrees
Device Size Text, specify: Length size 6.5
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Device Record Status

4d345069-9176-43a6-af80-aa6ed5d90f8b
October 26, 2022
1
October 18, 2022
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
888-247-0477
customerservice@surgixmedical.com
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