AccessGUDID - DEVICE: Talon™ DistalFix™ End Cap (B058SLN1550001)

GUDID

Device Identifier (DI) Information

Brand Name: Talon™ DistalFix™ End Cap
Version or Model: SLN155000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orthopedic Designs North America, Inc.

Primary DI Number: B058SLN1550001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945518848 *Terms of Use

Device Description: Talon™ DistalFix™ End Cap 15.5mm x Flush

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
Bone nail end-cap, sterile	A small, sterile, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Bone nail end-cap, sterile

A small, sterile, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. 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 [?]
K111352	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 0 Millimeter
Outer Diameter: 15.5 Millimeter

Device Record Status

Public Device Record Key: 102f7069-de18-497a-b5d3-5a3c7f0c53f3
Public Version Date: October 22, 2018
Public Version Number: 4
DI Record Publish Date: October 19, 2015