FDA.reportPublic FDA data

TRICAM®

Primary DI
04048551064160
Brand
TRICAM®
Company
Karl Storz GmbH & Co. KG
Model
20223011U1
Catalog number
20223011U1
Device description
CCU, TRICAM®, SL II, SCB
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAYLight Source System, Diagnostic Endoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAYLight Source System, Diagnostic EndoscopicUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P050027001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050027001KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEMKARL STORZ Endoscopy-America, Inc.2010-05-28OAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551064160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551064160040485510641604048551064160

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitA mains electricity (AC-powered) device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
424-218-8201su.chen@karlstorz.com
+14242188201su.chen@karlstorz.com
+14242188201regulatory@karlstorz.com

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
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
04048551441800NAKarl Storz GmbH & Co. KGOAY2025-03-27
04048551423530n.a.Karl Storz GmbH & Co. KGOAY2020-03-02
04048551423516n.a.Karl Storz GmbH & Co. KGOAY2020-03-02
04048551423547n.a.Karl Storz GmbH & Co. KGOAY2020-03-02
04048551063910n.a.Karl Storz GmbH & Co. KGOAY2018-08-21
04048551402528n.a.Karl Storz GmbH & Co. KGOAY2018-05-30
04048551402535n.a.Karl Storz GmbH & Co. KGOAY2018-05-30
04048551168639NAKarl Storz GmbH & Co. KGOAY2014-09-24
04048551064085TRICAM® Karl Storz GmbH & Co. KGOAY2014-09-24
04048551004654D-LIGHT CKarl Storz GmbH & Co. KGOAY2014-09-24
04048551064092TRICAM® Karl Storz GmbH & Co. KGOAY2014-09-24
04048551073094HOPKINS Karl Storz GmbH & Co. KGOAY2014-09-24
04048551073131HOPKINS Karl Storz GmbH & Co. KGOAY2014-09-24
04048551073209HOPKINS Karl Storz GmbH & Co. KGOAY2014-09-24
04048551289532HOPKINS Karl Storz GmbH & Co. KGOAY2014-09-24
04048551350652TRICAM® Karl Storz GmbH & Co. KGOAY2014-09-24