Osteoplug

GUDID 08885013201376

Dimensions: 13 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.

OSTEOPORE INTERNATIONAL PTE. LTD.

Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID08885013201376
NIH Device Record Key7e85449c-75b1-44f4-8782-0609b0454558
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoplug
Version Model NumberPC22(13,13,4)
Company DUNS894834738
Company NameOSTEOPORE INTERNATIONAL PTE. LTD.
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 Batchfalse
Serial Numbertrue
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

Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com
Phone9999999999
Emailcustomerservice@osteopore.com

Device Dimensions

Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter
Outer Diameter13 Millimeter
Depth4 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108885013201376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2020-08-18
Device Publish Date2020-08-10

On-Brand Devices [Osteoplug]

08885013201970Dimensions: 8 x 7 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is i
08885013201871Dimensions: 14 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201864Dimensions: 13 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201840Dimensions: 11 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201390Dimensions: 15 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201383Dimensions: 14 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201376Dimensions: 13 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201352Dimensions: 11 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201239Dimensions: 15 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201338Dimensions: 9 x 9 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is i
08885013201321Dimensions: 8 x 8 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is i
08885013201314Dimensions: 10 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201307Dimensions: 9 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inten

Trademark Results [Osteoplug]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSTEOPLUG
OSTEOPLUG
77566306 3605909 Dead/Cancelled
Swee Hin Teoh
2008-09-10
OSTEOPLUG
OSTEOPLUG
77566306 3605909 Dead/Cancelled
Soi Khoon Yew
2008-09-10
OSTEOPLUG
OSTEOPLUG
77250551 not registered Dead/Abandoned
Russell Cook
2007-08-08
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