FDA.reportPublic FDA data

G21 Flex Beads, 20cc

Primary DI
00850018568210
Brand
G21 Flex Beads, 20cc
Company
DIMENSIONAL BIOCERAMICS LLC
Model
900217 20
Catalog number
900217 20
Device description
CALCIUM SULFATE BONE VOID FILLER
Published
2024-06-06
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

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171161000Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)Dimensional Bioceramics, LLC2017-09-25MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018568210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018568210008500185682108500185682100850018568210

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
Total Volume20Milliliter

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
Manufacturing date on label
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
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
00850018568173CRANIOSCULPT-FLOWDB-C-FLOW20CCDB-C-FLOW20CC2020-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816125027125VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01