FDA.reportPublic FDA data

CranioSculpt

Primary DI
00813845020351
Brand
CranioSculpt
Company
SKELETAL KINETICS LLC
Model
C-FLOW5CC-OUS
Catalog number
C-FLOW5CC-OUS
Device description
CranioSculpt Flow Bone Void Filler
Published
2015-10-30
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813845020351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813845020351008138450203518138450203510813845020351

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile 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 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
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(972)677-4655cs@skeletalkinetics.com
+1(408)366-5014cs@skeletalkinetics.com

Regulatory Flags#

DUNS number
140071411
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813845021105CranioSculptC-C3CCC-C3CC2019-12-17
00813845021112CranioSculptC-C5CCC-C5CC2019-12-17
00813845021129CranioSculptC-C10CCC-C10CC2019-12-17
00842528104156OsteoMed390-6003390-60032017-04-20
00842528100172OsteoMed390-6005390-60052016-10-13
00842528100189OsteoMed390-6010390-60102016-10-13
00813845020009OsteoVation390-0002390-00022015-10-22
00813845020016OsteoVation390-0003390-00032015-10-22
00813845020023OsteoVation390-0005390-00052015-10-22
00813845020030OsteoVation390-0203390-02032015-10-22
00813845020047OsteoVation390-0205390-02052015-10-22
00813845020054OsteoVation390-2005390-20052015-10-22
00813845020061OsteoVation390-2010390-20102015-10-22
00813845020078OsteoVation390-2103390-21032015-10-22
00813845020085OsteoVation390-2105390-21052015-10-22
00813845020092OsteoVation390-2110390-21102015-10-22
00813845020115OsteoVation390-4002390-40022015-10-22
00813845020122OsteoVation390-4003390-40032015-10-22
00813845020139OsteoVation390-4005390-40052015-10-22
00813845020146OsteoVation390-4010390-40102015-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888118144430IPSKLS-Martin L.P.GXP2024-10-08
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00888118144485IPSKLS-Martin L.P.GXP2024-10-08
00888118144492IPSKLS-Martin L.P.GXP2024-10-08
00888118144508IPSKLS-Martin L.P.GXP2024-10-08
00888118144515IPSKLS-Martin L.P.GXP2024-10-08
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00888118144539IPSKLS-Martin L.P.GXP2024-10-08
00888118144546IPSKLS-Martin L.P.GXP2024-10-08
00888118144553IPSKLS-Martin L.P.GXP2024-10-08
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
08885013201307OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
08885013201314OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
00888118140050IPSKLS-Martin L.P.GXP2023-03-22
00888118140067IPSKLS-Martin L.P.GXP2023-03-22
00888118140074IPSKLS-Martin L.P.GXP2023-03-22
00888118140081IPSKLS-Martin L.P.GXP2023-03-22
00888118140098IPSKLS-Martin L.P.GXP2023-03-22
00888118140104IPSKLS-Martin L.P.GXP2023-03-22
00888118140111IPSKLS-Martin L.P.GXP2023-03-22
00888118140128IPSKLS-Martin L.P.GXP2023-03-22
00888118140135IPSKLS-Martin L.P.GXP2023-03-22
00888118140142IPSKLS-Martin L.P.GXP2023-03-22
00888118140159IPSKLS-Martin L.P.GXP2023-03-22