AccessGUDID - DEVICE: INSTRUMENT (07613327141627)

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Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 6079-6-615
Catalog Number: 6079-6-615
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327141627
Issuing Agency: GS1
Device Count: 1

Device Description: CURVED FLEXIBLE OSTEOTOME BLADE

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:	No
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
Orthopaedic osteotome blade	An interchangeable component of an orthopaedic osteotome that functions as the cutting blade and is attached and locked to a dedicated handle. Together, they become a single-blade, chisel-like, surgical instrument, typically bevelled on both sides with sloping curves, that is intended to to cut and/or shape bone by percussion during an orthopaedic procedure where the bone is typically used as a transplant. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. It is typically made of high-grade stainless steel. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic osteotome blade

An interchangeable component of an orthopaedic osteotome that functions as the cutting blade and is attached and locked to a dedicated handle. Together, they become a single-blade, chisel-like, surgical instrument, typically bevelled on both sides with sloping curves, that is intended to to cut and/or shape bone by percussion during an orthopaedic procedure where the bone is typically used as a transplant. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. It is typically made of high-grade stainless steel. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 15.0 Millimeter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: INSTRUMENT (07613327141627)