CRANIOSCULPT-C DB-C-C20CC

GUDID 00850018568135

CRANIAL BONE VOID FILLER

DIMENSIONAL BIOCERAMICS LLC

Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic
Primary Device ID00850018568135
NIH Device Record Keyfc8df227-f2ef-4418-88a2-2ef4ba45b506
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRANIOSCULPT-C
Version Model NumberDB-C-C20CC
Catalog NumberDB-C-C20CC
Company DUNS080276169
Company NameDIMENSIONAL BIOCERAMICS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Device Dimensions

Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]
GS100850018568135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty
GXPMethyl Methacrylate For Cranioplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [CRANIOSCULPT-C]

00850018568104CRANIAL BONE VOID FILLER
00850018568135CRANIAL BONE VOID FILLER
00850018568128CRANIAL BONE VOID FILLER
00850018568111CRANIAL BONE VOID FILLER

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