FDA.reportPublic FDA data

Insurgical, Inc.

Primary DI
00850056900102
Brand
Insurgical, Inc.
Company
Insurgical, Inc.
Model
320-0113-002
Catalog number
8010001
Device description
Sterile Transfer Shield
Published
2025-11-25
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
00850056900102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056900102008500569001028500569001020850056900102

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool battery-exchange sterility cover, single-useA cover that functions as a physical barrier between a battery and the sterile battery-powered surgical power tool (e.g., a drill or saw) in which the non-sterile battery is being placed/exchanged prior to a surgical procedure. It is typically made from high-grade stainless steel and/or synthetic material and is designed as a flange that fits into/around the slot where the battery is housed (typically in the handle of the power tool). This ensures that no contact is made between the sterile power tool and the person holding it inside the sterile operation field and the non-sterile battery and person loading the battery from outside the sterile field. This is a single-use device.

Sterilization Methods#

Method table
Method

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
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
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
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