FDA.reportPublic FDA data

INTELLIO Tablet

Primary DI
00885556866108
Brand
INTELLIO Tablet
Company
Smith & Nephew, Inc.
Model
72205719
Catalog number
72205719
Device description
INTELLIO TABLET COUNTRY KIT EN US
Published
2023-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K221929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221929000Smith+Nephew INTELLIO TabletSmith+Nephew2022-09-06ODA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556866108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556866108008855568661088855568661080885556866108

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
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010194534SYNERGY71306709713067092015-08-30
03596010194541SYNERGY71306710713067102015-08-30
03596010194558SYNERGY71306711713067112015-08-30
03596010194565SYNERGY71306712713067122015-08-30
03596010194572SYNERGY71306713713067132015-08-30
03596010194589SYNERGY71306714713067142015-08-30
03596010194596SYNERGY71306715713067152015-08-30
03596010194602SYNERGY71306716713067162015-08-30
03596010194619SYNERGY71306717713067172015-08-30
03596010194626SYNERGY71306718713067182015-08-30
03596010384935SYNERGY71306409713064092015-08-29
03596010384942SYNERGY71306410713064102015-08-29
03596010384966SYNERGY71306411713064112015-08-29
03596010384973SYNERGY71306412713064122015-08-29
03596010384980SYNERGY71306413713064132015-08-30
03596010384997SYNERGY71306414713064142015-08-30
03596010385000SYNERGY71306415713064152015-08-30
03596010385017SYNERGY71306416713064162015-08-30
03596010385024SYNERGY71306417713064172015-08-30
03596010385031SYNERGY71306418713064182015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556813683INTELLIO 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
00885556778777LENS CONNECTED TOWER APPLICATIONSmith & Nephew, Inc.ODA2020-03-22
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