AccessGUDID - DEVICE: INSTRUMENT (07613327207835)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 0580-4450-3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0580-4450-3
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327207835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: EXETER MODULAR RASP

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 rasp	A hand-held, manually-operated, file-like surgical instrument with a ridged surface of coarse grooves or teeth designed to be used in surgical procedures, typically orthopaedic surgery. It is made of high-grade steel and is used to scrape and smooth the surface of bone. It will have coarse cutting ridges along all or part of the distal working end and a handle at the proximal end. A rasp differs from a file in that the grooves or teeth are much coarser than a file so that they will not clog so easily and render the instrument unusable until cleaned of the debris. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Bone rasp

A hand-held, manually-operated, file-like surgical instrument with a ridged surface of coarse grooves or teeth designed to be used in surgical procedures, typically orthopaedic surgery. It is made of high-grade steel and is used to scrape and smooth the surface of bone. It will have coarse cutting ridges along all or part of the distal working end and a handle at the proximal end. A rasp differs from a file in that the grooves or teeth are much coarser than a file so that they will not clog so easily and render the instrument unusable until cleaned of the debris. This is a reusable device.

FDA Product Code

[?]

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

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: 3
Device Size Text, specify: Offset: 50.0 Millimeter

Device Record Status

Public Device Record Key: 5543215e-086d-4dd8-9291-22e627182f17
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016