FDA.reportPublic FDA data

HALL

Primary DI
10845854040164
Brand
HALL
Company
Conmed Corporation
Model
PRO6002T
Catalog number
PRO6002T
Device description
HALL LARGE STERILIZATION INNER TRAY
Published
2020-04-28
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
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
K090560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090560000CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYSConmed Linvatec2009-06-29KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854040161Direct MarkingGS10
10845854040164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084585404016120845854040161
1084585404016410845854040164

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24
20845854036584SEQUENTMR004CMR004C2015-10-24
10653405044703CORE DYNAMICSCD1406CD14062026-03-23
10653405045083CORE DYNAMICSCD1608FHCD1608FH2026-03-24
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094696INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094702INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094719INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094658INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094665INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094672INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094580INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094597INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094603INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094610INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094627INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094634INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094641INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00850092212009SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29
00860010729267STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729274STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729281SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29
00860010729298VERSAPODContainmed, Inc.KCT2026-09-29
07392532290282Astra Tech Implant System EV Surgical Tray GSDentsply Implants Manufacturing GmbHKCT2026-09-29
07392532290299Astra Tech Implant System EV Surgical TrayDentsply Implants Manufacturing GmbHKCT2026-09-29
00385640094566INSTRUSAFESummit Medical, Inc.KCT2026-09-28
00385640094573INSTRUSAFESummit Medical, Inc.KCT2026-09-28
G476TENZ20X10X2Tenzin SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-09-25
00385640094535INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094542INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094559INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00724995237059V. MuellerSteris CorporationKCT2026-09-24
00724995237066V. MuellerSteris CorporationKCT2026-09-24
00724995237073V. MuellerSteris CorporationKCT2026-09-24