CranioSculpt C-FORM5CC-CAN

GUDID 00813845020436

Bone matrix implant, synthetic

Primary Device ID	00813845020436
NIH Device Record Key	bf1c0a39-51d7-4c8a-8517-c0c66d2e9ad1
Commercial Distribution Status	In Commercial Distribution
Brand Name	CranioSculpt
Version Model Number	C-FORM5CC-CAN
Catalog Number	C-FORM5CC-CAN
Company DUNS	140071411
Company Name	SKELETAL KINETICS LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
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

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00813845020436 [Primary]

GXP	METHYL METHACRYLATE FOR CRANIOPLASTY

Steralize Prior To Use	false
Device Is Sterile	true

00813845020962	CranioSculpt CMF Bone Void Filler 25cc
00813845020955	CranioSculpt CMF Bone Void Filler 10cc
00813845020948	CranioSculpt Flow 5cc
00813845020931	CranioSculpt Flow 3cc
00813845020498	CranioSculpt Form, CAN, 25cc
00813845020481	CranioSculpt Form 25cc
00813845020474	CranioSculpt Form OUS, 10cc
00813845020467	CranioSculpt Form, CAN, 10cc
00813845020450	CranioSculpt Form 10cc
00813845020443	CranioSculpt Form OUS, 5cc
00813845020436	CranioSculpt Form, CAN, 5cc
00813845020429	CranioSculpt Form 5cc
00813845020412	CranioSculpt Form 3cc
00813845020405	CranioSculpt Flow, CAN, 25cc
00813845020399	CranioSculpt Flow 25cc
00813845020382	CranioSculpt Flow OUS 10cc
00813845020375	CranioSculpt Flow, CAN, 10cc
00813845020368	CranioSculpt Flow 10cc
00813845020351	CranioSculpt Form OUS, 5cc
00813845020344	CranioSculpt Form, CAN, 5cc
00813845020337	CranioSculpt Form 5cc
00813845020320	CranioSculpt Form 3cc
00813845021129	CranioSculpt C 10cc
00813845021112	CranioSculpt C 5cc
00813845021105	CranioSculpt C 3cc