FDA.reportPublic FDA data

Insurgical, Inc.

Primary DI
00860007230073
Brand
Insurgical, Inc.
Company
Insurgical, Inc.
Model
300-3002-001
Catalog number
3003022
Device description
14.4v Battery Pack Assembly
Published
2025-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MOQBattery, Replacement, Rechargeable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOQBattery, Replacement, RechargeableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007230073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007230073008600072300738600072300730860007230073

GMDN Terms#

Term, Definition table
TermDefinition
Portable/mobile rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Regulatory Flags#

DUNS number
078491571
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing 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
00860007230004Insurgical, Inc.320-0064-00130100012025-01-17
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
00860007230080Insurgical, Inc.360-0001-00130040252025-01-17

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Primary DI, Brand, Company table
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