FDA.report

n.a.

Primary DI
04048551102268
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
26182TD
Catalog number
26182TD
Device description
Changing Rod, ø 2.9 mm
Published
2019-02-23
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

Contact Domains

Product Codes

CodeName
NWWHysteroscope accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551102268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551102268040485511022684048551102268

GMDN Terms

TermDefinition
Endoscope sheath exchange guideAn invasive device in the form of a thin, rigid rod intended to provide guidance for exchanging one endoscope sheath, which has been introduced into a patient, for another (e.g., exchange a transvaginal diagnostic sheath with an operative sheath). It is intended to be inserted into the lumen of the initial sheath to guide sheath retraction and remain in situ to guide replacement sheath introduction; the guide is removed once the replacement sheath is in place. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+14242188201regulatory@karlstorz.com

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
true

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