FDA.reportPublic FDA data

Instrumentarium

Primary DI
00810055472222
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
s.50.724
Published
2021-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055472222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055472222008100554722228100554722220810055472222

GMDN Terms#

Term, Definition table
TermDefinition
Frontal sinus file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape, clean out, and enlarge the frontal sinus cavities during ear/nose/throat (ENT) surgery. It is available in two main designs: 1) a one-piece instrument that has circular cutting ridges at the tip of the curved distal working end and a handle at the proximal end; or 2) a tubular construction that allows for integrated suction (a tube from a suction system is connected to its proximal end) and a rasp (e.g., diamond coating) at the contoured working end. It is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203088166
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055470136InstrumentariumL.71.3252020-08-24
00810055470174InstrumentariumL.71.3302020-08-24
00810055471805InstrumentariumL.71.210.H2021-08-11
00810055471812InstrumentariumL.71.2112021-08-11
00810055471829InstrumentariumL.71.211.H2021-08-11
00810055471836InstrumentariumL.71.2152021-08-11
00810055471843InstrumentariumL.71.2252021-08-11
00810055471850InstrumentariumL.71.315.45.302021-08-11
00810055472000InstrumentariumL.71.997312021-08-11
00810055472017InstrumentariumL.71.997342021-08-11
00810055472024InstrumentariumL.72.2112021-08-11
00810055471324InstrumentariumL.70.2102021-01-13
00810055471331InstrumentariumL.70.2112021-01-13
00810055471348InstrumentariumL.70.2152021-01-13
00810055471355InstrumentariumL.70.2252021-01-13
00810055471362InstrumentariumL.70.3252021-01-13
00810055471379InstrumentariumL.70.3302021-01-13
00810055471096InstrumentariumL.99.00036262020-09-15
00810055470914InstrumentariumL.72.3152020-09-14
00810055470938InstrumentariumL.72.3252020-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431068MillenniumAvalign Technologies, Inc.FZS2026-09-21
M93071015023S10Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071015024S10Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715021C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715022C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715031C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715032C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
00840314270290gSourceGSOURCE LLCFZS2026-08-07
00810143906592SURGIPROSSurgipros, LLCFZS2026-07-30
00810143906608SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909777SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909784SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909807SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934136SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934143SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934150SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934167SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934174SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934181SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934198SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934204SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934211SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934228SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934235SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934242SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934259SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934266SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934273SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934280SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934297SURGIPROSSurgipros, LLCFZS2026-07-30