ORASTRUCT Orastruct-SYR-0.5

GUDID 03700501807197

Synthetic Resorbable Bone Graft Granules

BIOMATLANTE

Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID03700501807197
NIH Device Record Keyad852b3c-2215-49bd-a13f-05f0e857c5ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameORASTRUCT
Version Model NumberOrastruct-SYR-0.5
Catalog NumberOrastruct-SYR-0.5
Company DUNS493710719
Company NameBIOMATLANTE
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS103700501807197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18

Devices Manufactured by BIOMATLANTE

03700501813402 - RESORBA Synthetic Bone2024-05-27 Synthetic Bone Substitute - Resorbable Bone graft Granules 1-2 mm (1 cm3)
03700501813426 - RESORBA Synthetic Bone2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 60/40 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3) Syringe (x2)
03700501813440 - RESORBA Synthetic Bone2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3) Syringe (x1)
03700501813457 - RESORBA Synthetic Bone2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (1 cm3)
03700501813488 - RESORBA Synthetic Bone2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3) Syringe (x1)
03700501813495 - RESORBA Synthetic Bone2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3) Syringe (x2)
03700501813549 - RESORBA Synthetic Bone2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 1-2 mm (2 cm3)
03700501813501 - RESORBA Synthetic Bone2024-05-24 Injectable Bone Substitute 1G (80-200µm) Resorbable Bone Graft Injectable Bone Substitute 0.5 mL (x1)

Trademark Results [ORASTRUCT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORASTRUCT
ORASTRUCT
85613598 4302781 Live/Registered
Salvin Dental Specialties, Inc.
2012-05-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.