FDA.report

Instrumentarium

Primary DI
00810055471256
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
S.50.720
Published
2020-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KTGKnife, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KTGKnife, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810055471256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055471256008100554712568100554712560810055471256

GMDN Terms

TermDefinition
Laryngeal knifeA hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
203088166
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810055471539InstrumentariumL.70.7802021-08-11
00810055471546InstrumentariumL.70.7822021-08-11
00810055471553InstrumentariumL.70.7842021-08-11
00810055471560InstrumentariumL.70.9002021-08-11
00810055471577InstrumentariumL.70.9022021-08-11
00810055471584InstrumentariumL.70.9052021-08-11
00810055471591InstrumentariumL.70.9062021-08-11
00810055471607InstrumentariumL.70.9072021-08-11
00810055471614InstrumentariumL.70.9092021-08-11
00810055471621InstrumentariumL.70.9102021-08-11
00810055471638InstrumentariumL.70.9112021-08-11
00810055471645InstrumentariumL.70.9122021-08-11
00810055471652InstrumentariumL.70.9132021-08-11
00810055471669InstrumentariumL.70.9182021-08-11
00810055471676InstrumentariumL.70.9192021-08-11
00810055471683InstrumentariumL.70.920.S2021-08-11
00810055471690InstrumentariumL.70.9212021-08-11
00810055471706InstrumentariumL.70.921.S2021-08-11
00810055471713InstrumentariumL.70.9222021-08-11
00810055471720InstrumentariumL.70.9232021-08-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00757770429301Bausch + LombBausch & Lomb IncorporatedKTG2026-02-04
04250381870433SeparatorSpiggle & Theis Medizintechnik GmbHKTG2025-09-19
04250676723192Sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676735072KnifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676718600Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-12
04250676740595Teschner sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
04250676741790Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
00190776409371MillenniumAvalign Technologies, Inc.KTG2025-08-28
00190776409388MillenniumAvalign Technologies, Inc.KTG2025-08-28
00194613056377MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613056407MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
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00194613108700MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108762MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613118037MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613119621MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00757770422234Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00757770423699Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00190776406615MillenniumAvalign Technologies, Inc.KTG2025-07-23
00190776405694MillenniumAvalign Technologies, Inc.KTG2025-07-18
00190776397647MillenniumAvalign Technologies, Inc.KTG2025-05-16
00194613047504MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056353MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056360MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056391MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613107734MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613108625MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613109226MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
G141546380150Carnegie Surgical LLCCarnegie Surgical LLCKTG2025-02-03
00840183529284BR Surgical, LLCBR Surgical, LLCKTG2025-01-03