FDA.report

n.a.

Primary DI
04048551065891
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
20330070
Device description
Air detector
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HIGINSUFFLATOR, HYSTEROSCOPIC

Product Code Classifications

CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551065891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551065891040485510658914048551065891

GMDN Terms

TermDefinition
Surgical irrigation/aspiration system pumpA mains electricity (AC-powered) device used to generate positive and/or negative pressures as part of an irrigation/aspiration system used during a general surgical procedure to intermittently or continuously irrigate and/or aspirate body cavities and wounds. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

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