FDA.report

n.a.

Primary DI
04048551057100
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13991DA
Device description
Sealing cap working channel 10 pcs
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
FDFColonoscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551057100PrimaryGS10
04048551259627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551057100040485510571004048551057100
04048551259627040485512596274048551259627

GMDN Terms

TermDefinition
Rigid endoscope working guideAn endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;Peracetic Acid;Liquid Chemical

Regulatory Flags

DUNS number
315731430
Device count
10
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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