FDA.report

n.a.

Primary DI
04048551096314
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
26168G
Device description
Uterine Vacuum Cannula,large
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
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551096314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551096314040485510963144048551096314

GMDN Terms

TermDefinition
Intrauterine cannula, single-useA sterile, semi-rigid or rigid, plastic or, less frequently metal, tube designed for insertion into the uterus. It is frequently connected directly or through an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. It may also provide a port through which instruments and/or probes are passed to perform a variety of gynaecologic/obstetric diagnostic, therapeutic, and surgical procedures. This is a single-use 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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