FDA.reportPublic FDA data

CRANIOSCULPT-C

Primary DI
00850018568104
Brand
CRANIOSCULPT-C
Company
DIMENSIONAL BIOCERAMICS LLC
Model
DB-C-C3CC
Catalog number
DB-C-C3CC
Device description
CRANIAL BONE VOID FILLER
Published
2020-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K182742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182742000DB-CMFDimensional Bioceramics, LLC2019-06-20GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018568104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018568104008500185681048500185681040850018568104

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 Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080276169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018568197G21 Flex Beads, 5cc900217 5900217 52024-06-06
00850018568203G21 Flex Beads, 10cc900217 10900217 102024-06-06
00850018568210G21 Flex Beads, 20cc900217 20900217 202024-06-06
00850018568081Arthrex Calcium Sulfate BioBeads, 5 ccABS-3000-05ABS-3000-052023-09-05
00850018568098Arthrex Calcium Sulfate BioBeads, 10 ccABS-3000-10ABS-3000-102023-09-05
00850018568180Arthrex Calcium Sulfate BioBeads, 20 ccABS-3000-20ABS-3000-202023-09-05
00850018568005OsteoRepair-PasteDB-O-P3CCDB-O-P3CC2021-07-05
00850018568012OsteoRepair-PasteDB-O-P5CCDB-O-P5CC2021-07-05
00850018568029OsteoRepair-PasteDB-O-P10CCDB-O-P10CC2021-07-05
00850018568036OsteoRepair-PasteDB-O-P20CCDB-O-P20CC2021-07-05
00850018568043OsteoRepair-InjectDB-O-I3CCDB-O-I3CC2021-07-05
00850018568050OsteoRepair-InjectDB-O-I5CCDB-O-I5CC2021-07-05
00850018568067OsteoRepair-InjectDB-O-I10CCDB-O-I10CC2021-07-05
00850018568074OsteoRepair-InjectDB-O-I20CCDB-O-I20CC2021-07-05
00850018568111CRANIOSCULPT-CDB-C-C5CCDB-C-C5CC2020-06-09
00850018568128CRANIOSCULPT-CDB-C-C10CCDB-C-C10CC2020-06-09
00850018568135CRANIOSCULPT-CDB-C-C20CCDB-C-C20CC2020-06-09
00850018568142CRANIOSCULPT-FLOWDB-C-FLOW3CCDB-C-FLOW3CC2020-06-09
00850018568159CRANIOSCULPT-FLOWDB-C-FLOW5CCDB-C-FLOW5CC2020-06-09
00850018568166CRANIOSCULPT-FLOWDB-C-FLOW10CCDB-C-FLOW10CC2020-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118150271IPSKLS-Martin L.P.GXP2025-12-23
00850391007450Permatage 10ccABYRX, INC.GXP2025-05-21
00888118144430IPSKLS-Martin L.P.GXP2024-10-08
00888118144447IPSKLS-Martin L.P.GXP2024-10-08
00888118144454IPSKLS-Martin L.P.GXP2024-10-08
00888118144461IPSKLS-Martin L.P.GXP2024-10-08
00888118144478IPSKLS-Martin L.P.GXP2024-10-08
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
00888118144522IPSKLS-Martin L.P.GXP2024-10-08
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