Klassic HD Acetabular Insert with XLPE

GUDID 00814703015076

Non-constrained polyethylene acetabular liner

Primary Device ID	00814703015076
NIH Device Record Key	f7e28911-3b5a-4ac2-b2f2-db9d3ffa4da8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Klassic HD Acetabular Insert with XLPE
Version Model Number	3503.46.028
Company DUNS	078416717
Company Name	TOTAL JOINT ORTHOPEDICS, INC.
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	true
Serial Number	false
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 Size Text, specify	0
Device Size Text, specify	0

Special Storage Condition, Specify	Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Device Issuing Agency	Device ID
GS1	00814703015076 [Primary]

LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Steralize Prior To Use	true
Device Is Sterile	true

[00814703015076]

Ethylene Oxide

[00814703015076]

Ethylene Oxide

00814703015076	Acetabular Insert with XLPE, 28mm head, size 46mm
00814703015069	Acetabular Insert with XLPE, 28mm head, size 44mm
00814703015052	Acetabular Insert with XLPE, 22mm head, size 46mm
00814703015045	Acetabular Insert with XLPE, 22mm head, size 44mm