FDA.reportPublic FDA data

None

Primary DI
00886874113455
Brand
None
Company
INTUITIVE SURGICAL, INC.
Model
400220
Device description
STERILIZATION TRAY, SINGLE
Published
2016-07-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072211000INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYSIntuitive Surgical, Inc.2008-02-28KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886874113455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886874113455008868741134558868741134550886874113455

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
938647021
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886874121917Sureform48230B2022-05-11
00886874121924Sureform48230W2022-05-11
00886874121931Sureform48230M2022-05-11
00886874124871Ion Tomosynthesis Board3804562025-11-11
00886874111116EndoWrist;daVinci Si4103222016-08-03
00886874112069EndoWrist4280802016-08-03
00886874112106Single-Site; daVinci Si4280932016-08-03
00886874113707Single-Site4780802016-07-08
00886874113738Single-Site4780932016-08-03
00886874115664Endowrist4804222018-05-04
00886874117309da Vinci Energy4804402019-12-10
00886874120736Force Feedback4751722024-03-21
00886874120743Force Feedback4752052024-03-21
00886874123362da Vinci Energy4805222025-08-14
00886874125649Force Feedback4771722026-03-26
00886874125656Force Feedback4772052026-03-26
00886874125571Force Feedback4761722025-01-29
00886874125588Force Feedback4762052025-01-29
00886874123447EndoWrist SP4301512024-12-09
00886874123454EndoWrist SP4301002024-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095297INSTRUSAFESummit Medical, Inc.KCT2026-10-22
00642356006215Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006222Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006239Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006246Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006253SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006260SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006277SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006284SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006291SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006345SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006352SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006369SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006376SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006383SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006390SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006406SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006413SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006420SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006437SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006444SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006451SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006468SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006475SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006482SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006499SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006505SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006512SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006529SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006536SteriBestMastel Surgical Inc.KCT2026-10-22