FDA.reportPublic FDA data

DirectCell Advanced Bone Grafting System

Primary DI
00812593021542
Brand
DirectCell Advanced Bone Grafting System
Company
Biogennix, LLC
Model
BGS-8C-010-AGS
Catalog number
BGS-8C-010-AGS
Device description
Kit Contains: (1) 010-AGS, Medium 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
00812593021542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812593021542008125930215428125930215420812593021542

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
Contains natural rubber latex
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
00817295020589InradInradKNW2026-10-09
06937278634245CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278644121CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-06-30
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2024-12-05
10841156108441ONCONTROLTELEFLEX INCORPORATEDKNW2022-01-21
10841156108458ONCONTROLTELEFLEX INCORPORATEDKNW2022-01-21
10841156108465ONCONTROLTELEFLEX INCORPORATEDKNW2022-01-21
10841156108526ONCONTROLTELEFLEX INCORPORATEDKNW2022-01-21
10841156108649ONCONTROLTELEFLEX INCORPORATEDKNW2022-01-21
10841156108489ONCONTROLTELEFLEX INCORPORATEDKNW2022-01-20
10841156108632ONCONTROLTELEFLEX INCORPORATEDKNW2022-01-20
10841156108663ONCONTROLTELEFLEX INCORPORATEDKNW2022-01-20
10841156108472ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108496ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108502ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108540ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108564ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108588ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108601ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108625ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108656ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
10841156108670ONCONTROLTELEFLEX INCORPORATEDKNW2021-10-29
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00085412654362ALTAPOREApatech LtdMQV2019-12-11