FDA.reportPublic FDA data

AccuFill ® PreFill

Primary DI
00889024501225
Brand
AccuFill ® PreFill
Company
Etex Corporation
Model
206130
Catalog number
206130
Published
2019-12-18
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
FMFSyringe, Piston
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182107000
K190814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182107000CarriGen PFEtex Corporation2018-08-31MQV
K190814000AccuFill Bone Substitute MaterialZimmer Knee Creations2019-06-10MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024501225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024501225008890245012258890245012250889024501225

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
622221141
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024205444AccuFill®201.050201.0502015-11-02
00889024406476AccuFill®201.030201.0302015-11-02
00889024501232AccuFill ® PreFill2061502061502019-12-18
00889024563278N-Force Blue ™IN050-7IN050-72019-12-16
00889024563285N-Force Blue ™IN050-8IN050-82019-12-16
00889024205567CarriGen ® 76-60362015-10-24
00889024432826CarriGen76-603576-60352016-06-02
00889024205529EquivaBone ® 76-60272015-10-24
00889024205536EquivaBone ® 76-60212015-10-24
00889024205543EquivaBone ® 76-60222015-10-24
00889024205550EquivaBone ® 76-60412015-10-24
00889024205505Beta-bsm ® 76-60252015-10-24
00889024205512Beta-bsm ® 76-60162015-10-24
00889024499690Flow-FX271-002571-00252019-01-23
00889024499706Flow-FX271-005071-00252019-01-23
00889024563254N-Force BlueIN050-6IN050-62019-01-28
00889024563261N-Force BlueIN050-5IN050-52019-01-28
00889024205451Gamma-bsm ®76-60012015-10-24
00889024205468Gamma-bsm ®76-60232015-10-24
00889024205475Gamma-bsm ®76-60052015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
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