DEVICE: SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM (07540194003782)

Download: XML | JSON

Device Identifier (DI) Information

SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
SLM-56-110
SLM-56-110
Pega Medical Inc
07540194003782
GS1
1
SLIM Rod Ø5.6mm x 110mm
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HBS INSTRUMENT, CLIP FORMING/CUTTING
CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: keep at room temperature
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 5.6 Millimeter
Length: 110 Millimeter
CLOSE

Device Status

In Commercial Distribution
October 20, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(450)688-5144 242
egarcia@pegamedical.com
CLOSE