FDA.reportPublic FDA data

Instrumentarium

Primary DI
00810055471683
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
L.70.920.S
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
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055471683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055471683008100554716838100554716830810055471683

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704934598PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
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24026704934595PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934601PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934618PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
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04059453120823Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-12-05
00810130455461Medco ManufacturingMedco Manufacturing LLCGDM2025-11-05
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