FDA.report

n.a.

Primary DI
04048551064498
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
20300043
Device description
Silicone Tubing Set"CALCUSON"
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
FEOLithotriptor, ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551064498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551064498040485510644984048551064498

GMDN Terms

TermDefinition
Surgical suction systemAn assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 litter/min. The system is mainly used when suction from a central vacuum system is not available or appropriate.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true
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
true

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