FDA.reportPublic FDA data

miniARM® multiSTATION™ System

Primary DI
00850200006902
Brand
miniARM® multiSTATION™ System
Company
LSI Solutions, Inc.
Model
080555
Catalog number
080555
Device description
miniARM® LOCKING COUPLER - For use with the Olympus® ENDOEYE FLEX® 5mm HD surgical video camera (LTF-S190-5)(NOTE: the miniARM® Locking Coupler requires either 1) the miniARM® Cannula Adapter Kit (#080415) OR 2) the miniARM® Clamping Adapter (#080519) in order to be attached to the miniARM® Instrument Holder)
Published
2020-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXRHOLDER, CAMERA, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXRHolder, Camera, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850200006902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850200006902008502000069028502000069020850200006902

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system componentA non-patient-contact component of a surgical instrument assist arm system intended to be integrated as part of the structural assembly of the arm. It is a structural component (not a repair tool) and may be in the form of an arm piece/rod, base unit, clamp, actuator, or instrument holding component. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight130Gram

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)575-3493regulatorydpt@lsisolutions.com

Regulatory Flags#

DUNS number
603420183
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012846741JNW URTRAC0813000813002026-08-21
00850012846710ValveVault0820650820652026-07-08
00850012846703PicoDriver0234700234702026-04-28
00850012846246MD™ QUICK LOAD®0231600231602022-12-22
00850012846529RD® QUICK LOAD®0233870233872025-07-09
00850012846543RAM® COR-SUTURE® QUICK LOAD®0234070234072025-07-28
00850200006148RD® QUICK LOAD®0209790209792015-12-04
00850200006346COR-SUTURE® QUICK LOAD®0218610218612016-05-12
00850200006353COR-SUTURE® QUICK LOAD®0218620218622016-05-12
00850200006407RAM® COR-SUTURE® QUICK LOAD®0220900220902018-06-02
00850200006438RAM® COR-SUTURE® QUICK LOAD®0220470220472018-06-02
00850200006445RAM® COR-SUTURE® QUICK LOAD®0220390220392020-03-13
00850200006452RAM® COR-SUTURE® QUICK LOAD®0223350223352020-03-13
00850200006469RAM® COR-SUTURE® QUICK LOAD®0223200223202020-03-13
00850200006476RAM® COR-SUTURE® QUICK LOAD®0223250223252020-03-13
00850200006483RAM® COR-SUTURE® QUICK LOAD®0223400223402020-03-13
00850200006766RAM® COR-SUTURE® QUICK LOAD®0226680226682020-03-13
00850200006773RAM® COR-SUTURE® QUICK LOAD®0226710226712020-03-13
00850200006780RAM® COR-SUTURE® QUICK LOAD®0226740226742020-03-13
00850200006797RAM® COR-SUTURE® QUICK LOAD®0226800226802020-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867514263Arthrex®ARTHREX, INC.FXR2026-01-26
03700712414283Maquet EquipmentMAQUET SASFXR2025-01-06
03700712414290Maquet EquipmentMAQUET SASFXR2025-01-06
03700712414306Maquet EquipmentMAQUET SASFXR2025-01-06
03700712421403Maquet EquipmentMAQUET SASFXR2024-03-05
03700712422455Maquet EquipmentMAQUET SASFXR2024-03-05
03700712422462Maquet EquipmentMAQUET SASFXR2024-03-05
03700712432935Maquet EquipmentMAQUET SASFXR2023-12-15
03700712421410Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421427Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421434Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421441Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421458Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421465Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421472Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421489Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421496Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422240Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422257Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422264Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422271Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422288Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422295Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422301Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422318Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422325Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422332Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422349Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422356Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422363Maquet EquipmentMAQUET SASFXR2023-07-03