FDA.report

Instrumentarium

Primary DI
00810055470877
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
L.70.590.S
Published
2020-09-14
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
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications

CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810055470877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055470877008100554708778100554708770810055470877

GMDN Terms

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
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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24026704934618PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
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04059453120823Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-12-05
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D92810613410SUCTION TIP THREADED #4 W/ HOLEW.H. Holden, Inc.GDM2025-05-21
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00840516142685Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2025-02-28
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D928106121D450SUCTION TIP #1 REGULAR, 9 IN. LENGTH, 1MM, 45 DEGREE DOWN GRINDW.H. Holden, Inc.GDM2024-12-18
D928106121HV20SUCTION TIP #1 HI VOLUME B-STYLE, 9 IN. LENGTH, 1MMW.H. Holden, Inc.GDM2024-12-18