FDA.report

n.a.

Primary DI
04048551073902
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27023VS
Device description
Coil,for 27023VK
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
FGAKit, nephroscope

Product Code Classifications

CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551073902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551073902040485510739024048551073902

GMDN Terms

TermDefinition
Stone/foreign-body extraction setA collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. 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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