FDA.reportPublic FDA data

NA

Primary DI
G280NSI04400
Brand
NA
Company
Nsi US
Model
NSI-0440
Catalog number
NSI-0440
Device description
Clear-Line L/LS; Retractor Frame
Published
2022-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G280NSI04400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, reusableA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
303-860-0261info@nsi-healthsystems.com

Regulatory Flags#

DUNS number
100367091
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
G280NSICRS1NANSI-CRS1NSI-CRS12022-07-12
G280NSI30100NANSI-3010NSI-30102022-06-14
G280NSI3010G0NANSI-3010GNSI-3010G2022-06-14
G280NSI40100NANSI-4010NSI-40102022-06-14
G2805757990NA575-799575-7992022-06-03
G2805758000NA575-800575-8002022-06-03
G2805758030NA575-803575-8032022-06-03
G280MISCASEI00NAMIS Case IMIS Case I2022-06-03
G280MISCASEII00NAMIS Case IIMIS Case II2022-06-03
G280MISCASET100NAMIS Case T1MIS Case T12022-06-03
G280MISCASET200NAMIS Case T2MIS Case T22022-06-03
G280NSI10100NANSI-1010NSI-10102022-06-03
G280NSI20100NANSI-2010NSI-20102022-06-03
G280NSI50100NANSI-5010NSI-50102022-06-03
G280NSI50200NANSI-5020NSI-50202022-06-03
G280NSI1430R0NANSI-1430RNSI-1430R2022-07-12
G280NSI1440R0NANSI-1440RNSI-1440R2022-07-12
G280NSI1450R0NANSI-1450RNSI-1450R2022-07-12
G280NSI1460R0NANSI-1460RNSI-1460R2022-07-12
G280NSI1470R0NANSI-1470RNSI-1470R2022-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395483MillenniumAvalign Technologies, Inc.GAD2026-07-14
B382SD123750Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123760Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123780Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD124326191140Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209910FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209920FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209923FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907126105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247080T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247112T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD90724711T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907249100Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907284670Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907337510Surgical DirectSurgical Direct, Inc.GAD2026-07-14
G453152901750PEAK MEDICALPeak Medical Distribution Inc.GAD2026-07-14
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10