AccessGUDID - DEVICE: SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM (07540194004086)

GUDID

Device Identifier (DI) Information

Brand Name: SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
Version or Model: SLM-64-180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SLM-64-180
Company Name: Pega Medical Inc

Primary DI Number: 07540194004086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 257315713 *Terms of Use

Device Description: SLIM Rod Ø6.4mm x 180mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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

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Product Code	Product Code Name
HBS	INSTRUMENT, CLIP FORMING/CUTTING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143355	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam 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

Public Device Record Key: 44e6c9dc-2043-485e-9536-918fe3659915
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 20, 2016