DEVICE: GEN2 (G277G2N763070)
Device Identifier (DI) Information
GEN2
G2N76307
In Commercial Distribution
G2N76307
SURGIX MEDICAL LLC
G2N76307
In Commercial Distribution
G2N76307
SURGIX MEDICAL LLC
SPURLING IVD W/TEETH 4 X 10MM 7" STR
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? |
---|---|---|---|---|
35541 | Spinal rongeur |
A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HAE | Rongeur, Manual |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 7 Inch |
Device Size Text, specify: Direction Straight |
Device Size Text, specify: Tip Width 4MM |
Device Size Text, specify: Tip Length 10MM |
Device Record Status
8da97d5a-6bd3-4717-91ef-335c9cf9ce2e
October 07, 2022
1
September 29, 2022
October 07, 2022
1
September 29, 2022
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 |
---|---|
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