KYPHON Xpander KyphoPak Tray

GUDID 00763000031664

Balloon kyphoplasty kit

Primary Device ID	00763000031664
NIH Device Record Key	082732c7-d178-4b68-8486-15d072056ba0
Commercial Distribution Status	In Commercial Distribution
Brand Name	KYPHON Xpander KyphoPak Tray
Version Model Number	KPT1005
Company DUNS	830350380
Company Name	MEDTRONIC SOFAMOR DANEK, 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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place

Device Issuing Agency	Device ID
GS1	00763000031664 [Primary]

HRX	Arthroscope

Steralize Prior To Use	false
Device Is Sterile	true

00763000031794	KIT KPT2005 KYPAK TRY 20/3 FF W/ONE STEP
00763000031787	KIT KPT2004 KYPAK TRY 20/3 ADDL FRACTURE
00763000031770	KIT KPT2003 KYPAK TRY 20/3 FF W/ADV OIS
00763000031763	KIT KPT2002 KYPHOPAK TRAY 20/3 FF W/OIS
00763000031756	KIT KPT1505 KYPAK TRY 15/3 FF W/ONESTEP
00763000031749	KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE
00763000031732	KIT KPT1503 KYPAK TRY 15/3 FF W/ADV OIS
00763000031725	KIT KPT1502 KYPHOPAK TRAY 15/3 FF W/OIS
00763000031718	KIT KPT1004 KYPAK TRY 10/3 ADDL FRACTURE
00763000031701	KIT KPT1003 KYPAK TRAY 10/3 FFW/ADV OIS
00763000031664	KIT KPT1005 KYPAK TRY 10/3 FF W/ONESTEP
00763000031657	KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS