CRANIOSCULPT-FLOW DB-C-FLOW5CC

GUDID 00850018568159

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 ID00850018568159
NIH Device Record Keyf6c515d2-e055-4559-965b-ca443ac88b3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRANIOSCULPT-FLOW
Version Model NumberDB-C-FLOW5CC
Catalog NumberDB-C-FLOW5CC
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 Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 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
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [Primary]
GS100850018568159 [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-FLOW]

00850018568173CRANIAL BONE VOID FILLER
00850018568166CRANIAL BONE VOID FILLER
00850018568159CRANIAL BONE VOID FILLER
00850018568142CRANIAL BONE VOID FILLER

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