FDA.report

n.a.

Primary DI
04048551038345
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
PV27054EJ-1
Device description
Working Element
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
FBQTrocar, gastro-urology

Product Code Classifications

CodeDeviceSpecialtyClass
FBQTrocar, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551038345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551038345040485510383454048551038345

GMDN Terms

TermDefinition
Rigid endoscope working guideAn endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.

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
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
true

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