Osteoplug-C

GUDID 08885013201956

Dimensions: 14 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 Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID08885013201956
NIH Device Record Key53e117c2-d5db-4566-84c1-6397383157b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoplug-C
Version Model NumberPC24(14,14,4)
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 Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 Millimeter
Depth4 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter4 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
GS108885013201956 [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-C]

08885013201963Dimensions: 15 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201956Dimensions: 14 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201949Dimensions: 13 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
08885013201925Dimensions: 11 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is inte
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