AccessGUDID - DEVICE: FASSIER-DUVAL TELESCOPIC IM SYSTEM (07540194000422)

GUDID

Device Identifier (DI) Information

Brand Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM
Version or Model: FDLON-F048-SS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FDLON-F048-SS
Company Name: Pega Medical Inc

Primary DI Number: 07540194000422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 257315713 *Terms of Use

Device Description: LON Femoral Nail Assy Ø4.8 mm x 400mm

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
Femur nail, sterile	A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.
Humerus nail, sterile	A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the humerus, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.
Tibia nail, sterile	A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020885	000
K041393	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

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Storage and Handling
Special Storage Condition, Specify: keep at room temperature

Clinically Relevant Size

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Size Type Text
Outer Diameter: 4.8 Millimeter
Length: 400 Millimeter

Device Record Status

Public Device Record Key: 89628d96-fbf0-4383-a2c0-802cd608a1a2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 20, 2016