Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules 04-005-01-PIB

GUDID 00852108006305

Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.

CYTOPHIL, INC.

Dental bone matrix implant, synthetic
Primary Device ID00852108006305
NIH Device Record Key8f8f7e77-8d56-4779-9e86-dcc845a90969
Commercial Distribution Discontinuation2021-02-13
Commercial Distribution StatusIn Commercial Distribution
Brand NameBank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules
Version Model Number04-005-01-PIB
Catalog Number04-005-01-PIB
Company DUNS024222105
Company NameCYTOPHIL, INC.
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 Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852108006305 [Primary]

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-10-30

On-Brand Devices [Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules]

00852108006329Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indica
00852108006312Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indica
00852108006305Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indica

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