FDA.reportPublic FDA data

LENS CONNECTED TOWER APPLICATION

Primary DI
00885556778777
Brand
LENS CONNECTED TOWER APPLICATION
Company
Smith & Nephew, Inc.
Model
72205347
Catalog number
72205347
Device description
LENS CONNECTED TOWER APPLICATION
Published
2020-03-22
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
ODAendoscopic central control unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODAEndoscopic Central Control UnitGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192876000
K203566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192876000INTELLIO Tablet ApplicationSmith & Nephew2020-02-27ODA
K203566000Tablet ApplicationSmith & Nephew2021-05-13ODA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556778777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556778777008855567787778855567787770885556778777

GMDN Terms#

Term, Definition table
TermDefinition
Operating room audiovisual data/device management system application softwareAn application software program, routines, and/or algorithms intended to be used in an operating room audiovisual data/device management system to enable the system to function according to its intended purpose. The software typically supports remote control of medical and non-medical devices, data management/documentation, and data communication/transfer within and outside of the operating room (OR) [e.g., teleconferencing, teaching/ telesurgery, networking with hospital systems]; it is not intended for long-term storage of patient demographics. It is typically installed into a dedicated integrated network of computers and peripherals.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556813683INTELLIO TabletSmith & Nephew, Inc.ODA2023-05-17
00885556866108INTELLIO TabletSmith & Nephew, Inc.ODA2023-05-17
04953170435201SYSTEMS INTEGRATION ENDOALPHAOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-21
04953170328985UPGRADE KIT FOR UCES-3(Version4)OLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-17
04953170144929System CableOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-16
04953170148040Universal display for ENDOALPHAOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-16
04953170406461UCES-4 Upgrade Pack 2OLYMPUS MEDICAL SYSTEMS CORP.ODA2020-08-06
04048551416778n.a.Karl Storz GmbH & Co. KGODA2020-03-02
04953170391767MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391804EXTENSION UNIT FOR UCES-4OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391842INTERFACE FOR ESU (VIO SERIES)OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391873INTERFACE FOR ESU (FORCE SERIES)OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391903UNIVERSAL INTERFACEOLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391965INTERFACE FOR OLYMPUS LINK DEVICEOLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04048551242575n.a.Karl Storz GmbH & Co. KGODA2018-08-17
04048551357286n.a.Karl Storz GmbH & Co. KGODA2017-10-20
04048551392270n.a.Karl Storz GmbH & Co. KGODA2017-10-20
04953170136597REMOTE CABLEOLYMPUS MEDICAL SYSTEMS CORP.ODA2017-10-12
04055207013397NARichard Wolf GmbHODA2017-07-21
04055207013403NARichard Wolf GmbHODA2017-07-21
04055207013410NARichard Wolf GmbHODA2017-07-21
04055207013427NARichard Wolf GmbHODA2017-07-21
04055207013434NARichard Wolf GmbHODA2017-07-21
04055207013441NARichard Wolf GmbHODA2017-07-21
04055207041031NARichard Wolf GmbHODA2017-07-21
04055207057476NARichard Wolf GmbHODA2017-07-21
04055207057506NARichard Wolf GmbHODA2017-07-21
04055207057513NARichard Wolf GmbHODA2017-07-21
04055207057520NARichard Wolf GmbHODA2017-07-21
04055207057537NARichard Wolf GmbHODA2017-07-21