INSTRUMENT

Basic Information

• Brand Name: INSTRUMENT
• Primary DI: 07613327207828
• Version / Model: 0580-4450-4
• Catalog Number: 0580-4450-4
• Company Name: Howmedica Osteonics Corp.
• Labeler DUNS: 058311945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-10-31
• Public Version Status: Update
• Public Device Record Key: b88a906e-843d-4341-a7c9-38b0c9c98bff

Device Description

EXETER MODULAR RASP

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWL	Prosthesis, hip, hemi-, femoral, metal	Orthopedic	888.3360	2
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish	Orthopedic	888.3353	2
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous	Orthopedic	888.3358	2
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented	Orthopedic	888.3360	2
HWC	Screw, fixation, bone	Orthopedic	888.3040	2
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	Orthopedic	888.3390	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	Orthopedic	888.3310	2
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate	Orthopedic	888.3353	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35559	Bone file/rasp, manual, reusable	A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327207828	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size: 4
Device Size Text, specify			Offset: 50.0 Millimeter