SKaffold CMMP-IM10

GUDID 00813845020696

Skaffold CMF Impress (MP), 10cc

SKELETAL KINETICS LLC

Bone matrix implant, synthetic
Primary Device ID00813845020696
NIH Device Record Key0e0dee76-8dad-447c-b9e1-d863d2cf2cbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKaffold
Version Model NumberCMMP-IM10
Catalog NumberCMMP-IM10
Company DUNS140071411
Company NameSKELETAL KINETICS LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(972)677-4655
Emailcs@skeletalkinetics.com
Phone+1(972)677-4655
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com
Phone+1(408)366-5014
Emailcs@skeletalkinetics.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813845020696 [Primary]

FDA Product Code

GXPMETHYL METHACRYLATE FOR CRANIOPLASTY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-06-29
Device Publish Date2015-10-30

On-Brand Devices [SKaffold]

00813845020924Skaffold Impress (MX), 10cc
00813845020917Skaffold Impress (MX), 5cc
00813845020900Skaffold Flow (MX), 10cc
00813845020894Skaffold Flow (MX), 5cc
00813845020887Skaffold Flow (MX), 3cc
00813845020801Skaffold Impress 25cc
00813845020795Skaffold Impress 10cc
00813845020788Skaffold Impress 5cc
00813845020771Skaffold Flow 10cc
00813845020764Skaffold Flow 5cc
00813845020733Skaffold CMF Impress (MX), 10cc
00813845020726Skaffold CMF Impress (MX), 5cc
00813845020719Skaffold CMF Flow (MX), 10cc
00813845020702Skaffold CMF Flow (MX), 5cc
00813845020696Skaffold CMF Impress (MP), 10cc
00813845020689Skaffold CMF Impress (MP), 5cc

Trademark Results [SKaffold]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SKAFFOLD
SKAFFOLD
77734285 3832806 Live/Registered
Skeletal Kinetics LLC
2009-05-11

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