FDA.reportPublic FDA data

AccuFill ® PreFill

Primary DI
00889024501232
Brand
AccuFill ® PreFill
Company
Etex Corporation
Model
206150
Catalog number
206150
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
00889024501232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024501232008890245012328890245012320889024501232

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
00889024501225AccuFill ® PreFill2061302061302019-12-18
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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09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
00812013030291Instylla Delivery KitINSTYLLA INC.FMF2026-03-25
00812013030116Instylla Delivery KitINSTYLLA INC.FMF2025-09-18
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00763000827182inpen™MEDTRONIC MINIMED, INC.FMF2024-06-03
00763000827199inpen™MEDTRONIC MINIMED, INC.FMF2024-06-03
00763000827205inpen™MEDTRONIC MINIMED, INC.FMF2024-06-03
00763000827175inpen™MEDTRONIC MINIMED, INC.FMF2024-06-02
00763000827151inpen™MEDTRONIC MINIMED, INC.FMF2024-05-31
00763000827168inpen™MEDTRONIC MINIMED, INC.FMF2024-05-31
00732671021182LiteTouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-12-21
00732671022110LiteTouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-06-21
00732671022127LiteTouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-06-21
00732671022134LiteTouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-06-21
00732671022172LiteTouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-06-21
00732671022219Lite TouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-06-21
00732671020116Lite TouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-03-06
00732671020178Lite TouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-03-06
00732671020215Lite TouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-03-06
00732671021113LiteTouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-03-06
00732671021212LiteTouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-03-06
00732671021120Lite TouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-02-18
00732671021137LiteTouchAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMF2021-02-18
00812013030000Instylla Delivery KitINSTYLLA INC.FMF2020-11-20
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05