FDA.reportPublic FDA data

n.a.

Primary DI
04048551405604
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
24935
Device description
Operating Sigmoidoscope O.D.:30mm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCFPROCTOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCFProctoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945209000PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTSKARL STORZ Endoscopy-America, Inc.1995-03-06GCF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551405604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551405604040485514056044048551405604

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical rectoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during rectoscopy. Anatomical images are transmitted to the user typically through relayed lens optics. This device is longer than a proctoscope to provide a deeper view and it is typically equipped with illumination in the distal end. It is typically used to examine the structures of the rectum for irregularities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551084724n.a.Karl Storz GmbH & Co. KGGCF2018-08-21
04048551265420n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265437n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265444n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265475n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265499n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265505n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314500n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314524n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314555n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551229378n.a.Karl Storz GmbH & Co. KGGCF2017-10-20
04048551083307n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083390RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083420RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083628RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083666RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083727TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083741TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083840n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083888n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083901n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083956n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083970n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083994n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551084014TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084038TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084090TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084113TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084168n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551084434n.a.Karl Storz GmbH & Co. KGGCF2016-09-23