AccessGUDID - DEVICE: HUMERAL ENDCAP, FLUSH (00887868031441)

GUDID

Device Identifier (DI) Information

Brand Name: HUMERAL ENDCAP, FLUSH
Version or Model: 8003-01-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800301001
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868031441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

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	A small, sterile, rounded plug or cover designed to seal the proximal end of an orthopaedic nail after implantation. It prevents the healing tissue from growing inside the hollow nail that has been implanted to treat a damaged bone (e.g., a fracture) and facilitates nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes typically to fit the inner dimensions of the nail. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. It may be used with trochanteric, femoral, humeral, supracondylar or tibial nails. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Bone nail end-cap

A small, sterile, rounded plug or cover designed to seal the proximal end of an orthopaedic nail after implantation. It prevents the healing tissue from growing inside the hollow nail that has been implanted to treat a damaged bone (e.g., a fracture) and facilitates nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes typically to fit the inner dimensions of the nail. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. It may be used with trochanteric, femoral, humeral, supracondylar or tibial nails. 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 [?]
K934643	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8ee1a26c-4331-4dce-9541-2a8360d4d8d0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015