FDA.reportPublic FDA data

Next Gen Driver

Primary DI
M791NGD1005A0
Brand
Next Gen Driver
Company
BIOACCESS INC
Model
NGD1005A
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFFBur, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M791NGD1005A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motorized handpiece/set, electric, single-useAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes an electric motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery; the endpieces are not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
942203001
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M791TPK1237HTA0Traction Pin KitTPK1237HTATPK-1237-HTA2026-09-04
M791TPK1253HTA0Traction Pin KitTPK1253HTATPK-1253-HTA2026-09-04
M791NGD10000Next Gen DriverNGD10002022-08-04
M791SBT10000Small Bone ToolSBT10002022-08-04
M791SBT1000HT0Small Bone ToolSBT1000HT2022-08-04
M791SBT10010Small Bone ToolSBT10012022-08-04
M791SBT1001A0Small Bone ToolSBT1001A2022-08-04
M791SBT10040Small Bone ToolSBT10042022-08-04
M791SBT10050Small Bone ToolSBT10052022-08-04
M791SBT10050620Small Bone ToolSBT10050622022-08-04
M791SBT1005HTA0Small Bone ToolSBT1005HTA2022-08-04
M791WF1000Wire FixationWF1002022-08-04
M791MH21500BioAccess Marrow Collection SystemMH21502022-08-03
M791TPK12080Traction Pin KitTPK12082019-12-10
M791TPK11040Traction Pin KitTPK11042018-09-20
M791TPK1200HT0Traction Pin KitTPK1200HT2018-09-20
M791TPK12010Traction Pin KitTPK12012018-09-20
M791TPK1201HT0Traction Pin KitTPK1201HT2018-09-20
M791TPK1203HT0Traction Pin KitTPK1203HT2018-09-20
M791TPK1207HTA0Traction Pin KitTPK1207HTA2018-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000108G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000109G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000106AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-27
E226000104AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
E226000104G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
05051471027725De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471030152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089792De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089808De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089815De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089839De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089853De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089877De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29