FDA.reportPublic FDA data

HALL

Primary DI
30845854028593
Brand
HALL
Company
Conmed Corporation
Model
PRO6000
Catalog number
PRO6000
Device description
HALL SYSTEM STERILIZATION TRAY
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
30845854028593Direct MarkingGS10
10845854028599PrimaryGS10
20845854028596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084585402859330845854028593
1084585402859910845854028599
2084585402859620845854028596

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094016INSTRUSAFESummit Medical, Inc.KCT2026-08-19
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00385640093989INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640094009INSTRUSAFESummit Medical, Inc.KCT2026-08-18
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00724995239893V. MuellerSteris CorporationKCT2026-08-18
00724995240615V. MuellerSteris CorporationKCT2026-08-18
00724995240622V. MuellerSteris CorporationKCT2026-08-18
00724995240639V. MuellerSteris CorporationKCT2026-08-18
00724995240714V. MuellerSteris CorporationKCT2026-08-18
00724995240721V. MuellerSteris CorporationKCT2026-08-18
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00724995240752V. MuellerSteris CorporationKCT2026-08-18
00724995240769V. MuellerSteris CorporationKCT2026-08-18
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00724995240820V. MuellerSteris CorporationKCT2026-08-18
00724995240837V. MuellerSteris CorporationKCT2026-08-18
00724995240844V. MuellerSteris CorporationKCT2026-08-18
00724995240851V. MuellerSteris CorporationKCT2026-08-18
00724995240868V. MuellerSteris CorporationKCT2026-08-18
00724995240875V. MuellerSteris CorporationKCT2026-08-18
00724995240882V. MuellerSteris CorporationKCT2026-08-18
00724995240899V. MuellerSteris CorporationKCT2026-08-18