FDA.report

n.a.

Primary DI
04048551080368
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27095CR
Device description
Guide rod, rigid, for 27095 C
Published
2017-10-20
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
04048551080368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551080368040485510803684048551080368

GMDN Terms

TermDefinition
Urethral bougie, reusableA rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. 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
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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04048551012468NA11900RA11900RA2025-03-28
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07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2024-09-03
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00821925043794SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043800SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043824SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043725SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043732SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043749SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043756SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043763SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043817OlympusGyrus Acmi, Inc.FEO2024-07-23
04953170026782Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-18
04953170318818Probe for LUS-2 2.0mm O.D.OLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-17
04953170026799Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-16
00821925043671ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043688ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043695ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043701ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043718ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925044203ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043831ShockPulseGyrus Acmi, Inc.FEO2020-03-02
00821925044197ShockPulseGyrus Acmi, Inc.FEO2020-03-02
07613353125912LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2019-11-15
00821925039445SHOCKPULSE LITHOTRIPSY WRENCHGyrus Acmi, Inc.FEO2018-09-14
07613353156114LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03
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07613353157982LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162559LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162566LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
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