FDA.reportPublic FDA data

NA

Primary DI
G280NSI6075A0
Brand
NA
Company
Nsi US
Model
NSI-6075A
Catalog number
NSI-6075A
Device description
60mm x 75mm Clear-Line L; Blade
Published
2022-06-13
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
G280NSI6075A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Width75Millimeter

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
00190776433086MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433116MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433154MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433161MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776432959MillenniumAvalign Technologies, Inc.GAD2026-09-30
00190776432997MillenniumAvalign Technologies, Inc.GAD2026-09-30
G1415180500Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141518555120Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141528202010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572105820Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572106810Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572108210Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157211460Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157212010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157213040Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
00190776432874MillenniumAvalign Technologies, Inc.GAD2026-09-29
00190776432515MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432591MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432621MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432638MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432669MillenniumAvalign Technologies, Inc.GAD2026-09-28
00840329838829N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329838980N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839000N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839017N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24