DEVICE: GAP ENDO-EXO MEDULLARY SYSTEM (07540194002006)
Device Identifier (DI) Information
GAP ENDO-EXO MEDULLARY SYSTEM
GAP-CS4-34/GAP-WAS100
In Commercial Distribution
GAP-CS4-34/GAP-WAS100
Pega Medical Inc
GAP-CS4-34/GAP-WAS100
In Commercial Distribution
GAP-CS4-34/GAP-WAS100
Pega Medical Inc
Cortical Screw & Washer Ø4.0mm X 34mm
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? |
---|---|---|---|---|
44854 | Arthrodesis nail, fixed-length |
A rod of fixed-length (i.e., not intended for distraction) intended to be implanted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] for the purpose of joint fusion or arthrodesis; it is not dedicated to femur or tibia implantation. The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: keep at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 34 Millimeter |
Outer Diameter: 4 Millimeter |
Device Record Status
f0d1c109-4cf6-4fc0-8d86-6387421e06ac
September 18, 2023
4
October 20, 2016
September 18, 2023
4
October 20, 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 |
---|---|---|---|---|---|
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
[?]
+1(450)688-5144
242
egarcia@pegamedical.com
egarcia@pegamedical.com