FDA.reportPublic FDA data

DirectCell Advanced Bone Grafting System

Primary DI
00812593021559
Brand
DirectCell Advanced Bone Grafting System
Company
Biogennix, LLC
Model
BGS-8C-020-AGS
Catalog number
BGS-8C-020-AGS
Device description
Kit Contains: (1) 020-AGS, Large Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cellution Bone Marrow Biopsy Kit
Published
2021-02-24
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
KNWInstrument, Biopsy
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190177000
K193487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190177000J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation2019-06-12KNW
K193487000Agilon StripBiogennix, LLC2020-03-30MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812593021559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812593021559008125930215598125930215590812593021559

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832270370
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812593023188osteoSPAN Granules120-10G2026-07-24
00812593023195SUMMIT Matrix Granules 10cc9241102026-07-24
00812593023201SUMMIT Matrix Granules 30cc9241302026-07-24
00812593023119NeoForm AWCNFAWC-0252026-04-27
00812593023126NeoForm AWCNFAWC-0502026-04-27
00812593023072NeoSurg Surgical CollagenNSC-3122026-04-22
00812593023089ossFX Surgical CollagenAXB-OSF-2502026-04-22
00812593023096ossFX Surgical CollagenAXB-OSF-5002026-04-22
00812593023102ColSyntekZS3001-52026-04-22
00812593023058Agilon Surgical Collagen +ASC-0152026-04-02
00812593023065Agilon Surgical Collagen +ASC-0302026-04-02
00812593023034CuraSurg Surgical CollagenCSC-0252026-04-01
00812593023041CuraSurg Surgical CollagenCSC-0502026-04-01
00812593023010Agilon Surgical Collagen+ASC-0252026-03-24
00812593023027Agilon Surgical Collagen+ASC-0502026-03-24
00812593021931Summit Moldable9242012025-02-21
00812593021948Summit Moldable9242022025-02-21
00812593021955Summit Moldable9242052025-02-21
00812593021962Summit Moldable9242102025-02-21
00812593021979Summit Strip9243052025-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635013CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635020CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635037CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635075CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635082CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635112CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635129CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635136CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635167CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635174CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635181CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635211CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635228CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635235CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635266CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635273CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635280CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635310CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635327CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15