FDA.report

Instrumentarium

Primary DI
00810055471072
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
L.71.943.30
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
KAEForceps, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810055471072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055471072008100554710728100554710720810055471072

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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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