Initia Total Hip System GMH02-100026

GUDID 04580810056412

Metal-on-polyethylene total hip prosthesis

Primary Device ID	04580810056412
NIH Device Record Key	b0c9e67b-1714-451e-8427-34587af0b1bc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Initia Total Hip System
Version Model Number	GMH02-100026
Catalog Number	GMH02-100026
Company DUNS	691363290
Company Name	KYOCERA MEDICAL 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

Device Issuing Agency	Device ID
GS1	04547898305641 [Previous]
GS1	04580810056412 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	true

04580810059116	INITIA STEM HO #11 "Size: #11 Stem: High offset Taper: 12/14 Stem length: 119mm Neck length: 40
04580810059109	INITIA STEM HO #10 "Size: #10 Stem: High offset Taper: 12/14 Stem length: 117mm Neck length: 40
04580810059093	INITIA STEM HO #9 "Size: #9 Stem: High offset Taper: 12/14 Stem length: 115mm Neck length: 39mm
04580810059079	INITIA STEM HO #7 "Size: #7 Stem: High offset Taper: 12/14 Stem length: 111mm Neck length: 40mm
04580810059062	INITIA STEM HO #6.5 "Size: #6.5 Stem: High offset Taper: 12/14 Stem length: 109mm Neck length: 3
04580810059055	INITIA STEM HO #6 "Size: #6 Stem: High offset Taper: 12/14 Stem length: 107mm Neck length: 39mm
04580810059017	INITIA STEM HO #4 "Size: #4 Stem: High offset Taper: 12/14 Stem length: 102mm Neck length: 37mm
04580810058928	INITIA STEM STD #11 "Size: #11 Stem: Standard offset Taper: 12/14 Stem length: 119mm Neck length
04580810058874	INITIA STEM STD #6.5 "Size: #6.5 Stem: Standard offset Taper: 12/14 Stem length: 109mm Neck leng
04580810058294	STD LINER 36-60/64 "Size:36-60/62/64 Type:Flat 36mm I.D. 60/62/64mm O.D."
04580810058263	STD LINER 36-50 "Size:36-50 Type:Flat 36mm I.D. 50mm O.D."
04580810056429	INITIA SHELL 56-3H "Size: φ56MM O.D. Type: 3 HOLE"
04580810056412	INITIA SHELL 54-3H "Size: φ54MM O.D. Type: 3 HOLE"
04580810056405	INITIA SHELL 52-3H "Size: φ52MM O.D. Type: 3 HOLE"
04580810056252	INITIA SHELL 58-7H "Size: φ58MM O.D. Type: 7 HOLE"
04580810056221	INITIA SHELL 52-7H "Size: φ52MM O.D. Type: 7 HOLE"