AccessGUDID - DEVICE: INSTRUMENT (07613327209365)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 1111-1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1111-1001
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327209365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: TROCHANTERIC REAMER

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

[?]

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, reusable	An 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). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Bone-resection orthopaedic reamer, reusable

An 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). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWL	Prosthesis, hip, hemi-, femoral, metal
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
HWC	Screw, fixation, bone
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

FDA Premarket Submission

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

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size: SM
Device Size Text, specify: Diameter: 15.0 Millimeter

Device Record Status

Public Device Record Key: 405ccd30-e116-4773-a391-94b592c94773
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016