FDA.reportPublic FDA data

n.a.

Primary DI
04048551084724
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
24960B
Device description
Fiber Optic Light Carrier
Published
2018-08-21
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
04048551084724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551084724040485510847244048551084724

GMDN Terms#

Term, Definition table
TermDefinition
Optical proctoscope, 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 proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Lot or batch
true
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
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
04048551084472n.a.Karl Storz GmbH & Co. KGGCF2016-09-23