FDA.reportPublic FDA data

Insurgical, Inc.

Primary DI
00860007230004
Brand
Insurgical, Inc.
Company
Insurgical, Inc.
Model
320-0064-001
Catalog number
3010001
Device description
Drill-Reamer Packaged Assembly
Published
2025-01-17
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
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007230004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007230004008600072300048600072300040860007230004

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.

Regulatory Flags#

DUNS number
078491571
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056900102Insurgical, Inc.320-0113-00280100012025-11-25
00850056900119Insurgical, Inc.320-0301-0023010001-R2025-11-25
00850056900126Insurgical, Inc.320-0302-0023010002-R2025-11-25
00850056900133Insurgical, Inc.320-0303-0023010003-R2025-11-25
00850056900140Insurgical, Inc.320-0201-00230100012025-11-25
00850056900157Insurgical, Inc.320-0202-00230100022025-11-25
00850056900164Insurgical, Inc.320-0203-00230100032025-11-25
00850056900089Insurgical, Inc.320-0110-00130030232025-01-17
00860007230028Insurgical, Inc.320-0071-00130100032025-01-17
00860007230035Insurgical, Inc.320-0067-00130100022025-01-17
00860007230042Insurgical, Inc.670-0003-00192500122025-01-17
00860007230059Insurgical, Inc.320-0107-00192500232025-01-17
00860007230066Insurgical, Inc.320-0070-00192500222025-01-17
00860007230073Insurgical, Inc.300-3002-00130030222025-01-17
00860007230080Insurgical, Inc.360-0001-00130040252025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260475649TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-05-19
08800038060807EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08800038060814EZImpactorIMEDICOM CO., LTD.KIJ2026-04-21
08809260473812TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473829TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473836TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473843TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473850TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473867TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473874TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473881TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473898TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473904TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260473911TRAUSSaeshin Precision Co., Ltd.KIJ2026-04-09
08809260474598TRAUS SSG20Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475182TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475526SSG20Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475533SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475540SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08809260475557SSG40Saeshin Precision Co., Ltd.KIJ2026-04-09
08800038060784EZImpactorIMEDICOM CO., LTD.KIJ2026-04-01
08800038060791EZImpactorIMEDICOM CO., LTD.KIJ2026-04-01
10603295559511INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559597INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559771INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559801INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
10603295559825INHANCE INTACTDEPUY (IRELAND)KIJ2025-06-13
00840286841603Consensus Hip SystemShalby Advanced Technologies, Inc.KIJ2025-05-22
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00840286841627Consensus Hip SystemShalby Advanced Technologies, Inc.KIJ2025-05-22