FDA.reportPublic FDA data

Instrumentarium

Primary DI
00810055470921
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
L.70.601
Published
2020-09-14
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
00810055470921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055470921008100554709218100554709210810055470921

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal injection kitA collection of surgical instruments, pharmaceuticals, and other items (e.g., dressings) intended to be used to perform an injection in the region of the larynx. 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
No natural rubber latex
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
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