Osteomesh

Primary DI
08885013200577
Brand
Osteomesh
Company
OSTEOPORE INTERNATIONAL PTE. LTD.
Model
PC12(39,10,1)
Device description
Dimensions: 39 x 10 x 1 mm Material: PCLIntended 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.
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXPMethyl Methacrylate For Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051093000OSTEOPORE PCL SCAFFOLDOsteopore, Inc.2006-03-17GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885013200577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885013200577088850132005778885013200577

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth1Millimeter
Length39Millimeter
Width10Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@osteopore.com

Regulatory Flags#

DUNS number
894834738
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08885013201307OsteoplugPC23(9,9,4)2023-08-02
08885013201314OsteoplugPC23(10,10,4)2023-08-02
08885013200133OsteomeshPC11(50,50,1.5)2022-09-26
08885013201321OsteoplugPC22(8,8,4)2022-09-26
08885013201338OsteoplugPC22(9,9,4)2022-09-26
08885013200041OsteomeshPC11(25,25,1)2020-08-10
08885013200140OsteomeshPC11(50,50,2)2020-08-10
08885013200195OsteostripPC17(100,3.5,4)2020-08-10
08885013200409OsteostripPC17(100,2,4)2020-08-10
08885013200478OsteostripPC18(60,3.5,4)2020-08-10
08885013200485OsteostripPC18(60,2,4)2020-08-10
08885013200508OsteomeshPC12(39,10,1.25)2020-08-10
08885013200546OsteomeshPC51(13,8,4,6)2020-08-10
08885013201239OsteoplugPC23(15,15,4)2020-08-10
08885013201352OsteoplugPC22(11,11,4)2020-08-10
08885013201376OsteoplugPC22(13,13,4)2020-08-10
08885013201383OsteoplugPC22(14,14,4)2020-08-10
08885013201390OsteoplugPC22(15,15,4)2020-08-10
08885013201840OsteoplugPC23(11,11,4)2020-08-10
08885013201864OsteoplugPC23(13,13,4)2020-08-10

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08885013201314OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
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