FDA.report

Instrumentarium

Primary DI
00810055471522
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
L.70.606
Published
2021-01-13
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
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810055471522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055471522008100554715228100554715220810055471522

GMDN Terms

TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. 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

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