FDA.report

n.a.

Primary DI
04048551259115
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
20925000
Device description
Iris for Zeiss PENTERO
Published
2020-03-02
Public version status
New
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
EPTMICROSCOPE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EPTMicroscope, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551259115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551259115040485512591154048551259115

GMDN Terms

TermDefinition
Endoscope camera adaptorA device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
true
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
false

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04048438008911NA051110-10051110-102025-03-28
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04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

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