Initia Total Hip System GMH02-500015

GUDID 04547898304750

INITIA STEM STD #2

KYOCERA CORPORATION

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04547898304750
• NIH Device Record Key: 3e868e89-8ac0-4860-ac25-bbfc40386a40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Initia Total Hip System
• Version Model Number: GMH02-500015
• Catalog Number: GMH02-500015
• Company DUNS: 694697025
• Company Name: KYOCERA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com

Device Dimensions

• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04547898304750 [Primary]

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-18
• Device Publish Date: 2017-02-21

On-Brand Devices [Initia Total Hip System]

• 04547898737541: STD-HO LINER TRIAL 28-44
• 04547898737534: STD-HO LINER TRIAL 40-72/74
• 04547898737527: STD-HO LINER TRIAL 36-72/74
• 04547898737510: STD-HO LINER TRIAL 32-72/74
• 04547898737503: STD-HO LINER TRIAL 40-66/68/70
• 04547898737497: STD-HO LINER TRIAL 36-66/68/70
• 04547898737480: STD-HO LINER TRIAL 32-66/68/70
• 04547898737473: STD-HO LINER TRIAL 40-60/62/64
• 04547898737466: STD-HO LINER TRIAL 36-60/62/64
• 04547898737459: STD-HO LINER TRIAL 32-60/62/64
• 04547898737442: STD-HO LINER TRIAL 40-56/58
• 04547898737435: STD-HO LINER TRIAL 36-56/58
• 04547898737428: STD-HO LINER TRIAL 32-56/58
• 04547898737411: STD-HO LINER TRIAL 36-52/54
• 04547898737404: STD-HO LINER TRIAL 32-52/54
• 04547898737398: STD-HO LINER TRIAL 36-50
• 04547898737381: STD-HO LINER TRIAL 32-50
• 04547898737374: STD-HO LINER TRIAL 28-50
• 04547898737367: STD-HO LINER TRIAL 32-48
• 04547898737350: STD-HO LINER TRIAL 28-48
• 04547898737343: STD-HO LINER TRIAL 32-46
• 04547898737336: STD-HO LINER TRIAL 28-46
• 04547898737312: STD LINER TRIAL 28-44
• 04547898737305: STD LINER TRIAL 40-72/74
• 04547898737299: STD LINER TRIAL 36-72/74
• 04547898737282: STD LINER TRIAL 32-72/74
• 04547898737275: STD LINER TRIAL 40-66/68/70
• 04547898737268: STD LINER TRIAL 36-66/68/70
• 04547898737251: STD LINER TRIAL 32-66/68/70
• 04547898737244: STD LINER TRIAL 40-60/62/64
• 04547898737237: STD LINER TRIAL 36-60/62/64
• 04547898737220: STD LINER TRIAL 32-60/62/64
• 04547898737213: STD LINER TRIAL 40-56/58
• 04547898737206: STD LINER TRIAL 36-56/58
• 04547898737190: STD LINER TRIAL 32-56/58
• 04547898737183: STD LINER TRIAL 36-52/54
• 04547898737176: STD LINER TRIAL 32-52/54
• 04547898737169: STD LINER TRIAL 36-50
• 04547898737152: STD LINER TRIAL 32-50
• 04547898737145: STD LINER TRIAL 28-50
• 04547898737138: STD LINER TRIAL 32-48
• 04547898737121: STD LINER TRIAL 28-48
• 04547898737114: STD LINER TRIAL 32-46
• 04547898737107: STD LINER TRIAL 28-46
• 04547898736933: INITIA BROACH 10
• 04547898736926: INITIA BROACH 9
• 04547898736919: MALLET
• 04547898736902: FEMORAL BROACH TRAY
• 04547898736513: MX-HO LINER TRIAL 28-44
• 04547898736506: MX-HO LINER TRIAL 28-50