AccessGUDID - DEVICE: INSTRUMENT (07613327014433)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 8000-0036
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8000-0036
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327014433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: PATELLA CUTTER

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

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Bone-resection orthopaedic reamer, single-use	A sterile, orthopaedic, surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy available in varying sizes. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Bone-resection orthopaedic reamer, single-use

A sterile, orthopaedic, surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy available in varying sizes. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Thickness: 12.0 Millimeter
Device Size Text, specify: Diameter: 36.0 Millimeter

Device Record Status

Public Device Record Key: 07caa61b-3fd5-4f37-b0f9-a3276852c7a0
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016