DEVICE: SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM (07540194004086)
Device Identifier (DI) Information
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
SLM-64-180
In Commercial Distribution
SLM-64-180
Pega Medical Inc
SLM-64-180
In Commercial Distribution
SLM-64-180
Pega Medical Inc
SLIM Rod Ø6.4mm x 180mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Arthrodesis nail, sterile | A sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HBS | INSTRUMENT, CLIP FORMING/CUTTING |
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: 180 Millimeter |
Outer Diameter: 6.4 Millimeter |
Device Record Status
44e6c9dc-2043-485e-9536-918fe3659915
March 29, 2018
2
October 20, 2016
March 29, 2018
2
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