FDA.report

NA

Primary DI
G280NSI01060
Brand
NA
Company
Nsi US
Model
NSI-0106
Catalog number
NSI-0106
Device description
Screwdriver
Published
2022-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRZScrewdriver, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G280NSI01060PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical screwdriver, single-use, non-sterileA non-sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
303-860-0261info@nsi-healthsystems.com

Regulatory Flags

DUNS number
100367091
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
G280NSI1480R0NANSI-1480RNSI-1480R2022-07-12
G280NSI1490R0NANSI-1490RNSI-1490R2022-07-12
G280NSI1630R0NANSI-1630RNSI-1630R2022-07-12
G280NSI1640R0NANSI-1640RNSI-1640R2022-07-12
G280NSI1650R0NANSI-1650RNSI-1650R2022-07-12
G280NSI1660R0NANSI-1660RNSI-1660R2022-07-12
G280NSI1670R0NANSI-1670RNSI-1670R2022-07-12
G280NSI1680R0NANSI-1680RNSI-1680R2022-07-12
G280NSI1690R0NANSI-1690RNSI-1690R2022-07-12
G280NSI1830R0NANSI-1830RNSI-1830R2022-07-12
G280NSI1840R0NANSI-1840RNSI-1840R2022-07-12
G280NSI1850R0NANSI-1850RNSI-1850R2022-07-12
G280NSI1860R0NANSI-1860RNSI-1860R2022-07-12
G280NSI1870R0NANSI-1870RNSI-1870R2022-07-12
G280NSI1880R0NANSI-1880RNSI-1880R2022-07-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800016101362Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114447Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114454Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114461Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114478Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114485Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115024Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115840Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115857Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016116014Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016144772Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163087Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163094Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176742Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176759Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176766Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176773Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176780Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176797Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176810Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176827Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176834Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176872Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176896Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176902Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176919Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
00840199515691Hex Screw DriverKOROS U.S.A., INC.LRZ2024-12-31
00840199515967ScrewdriverKOROS U.S.A., INC.LRZ2024-12-31
03700751501456BE POD MEDIO AR PIED POIGNEE DROITE MINI AOASKORN MEDICALLRZ2024-12-19
00858816006088Ziptek knotless tissue repair and attachment devicesZIPTEK LLCLRZ2024-07-19