FDA.reportPublic FDA data

Halyard

Primary DI
30680651474255
Brand
Halyard
Company
O&M HALYARD, INC.
Model
47425
Catalog number
47425
Device description
STERISYSTEM® Accessories DRY-BASE® Stainless Steel Instrument Tray
Published
2022-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K203177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203177000Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc.2022-01-02KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651474255PrimaryGS10
90680651474257Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065147425530680651474255
9068065147425790680651474257

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
081057389
Device count
12
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651497639Halyard49763ARMOR242026-07-16
20680651497646Halyard49764ARMOR362026-07-16
20680651497653Halyard49765ARMOR402026-07-16
20680651497660Halyard49766ARMOR452026-07-16
20680651497677Halyard49767ARMOR482026-07-16
20680651497684Halyard49768ARMOR542026-07-16
30680651496936Halyard49693496932025-05-17
30680651496943Halyard49694496942025-05-17
30680651496950Halyard49695496952025-05-17
30680651496967Halyard49696496962025-05-17
30680651496974Halyard49697496972025-05-17
30680651496981Halyard49698496982025-05-17
30680651501272Halyard50127NS50127NS2026-06-08
30680651501289Halyard50128NS50128NS2026-06-08
30680651501296Halyard50129NS50129NS2026-06-08
30680651501302Halyard50130NS50130NS2026-06-08
10680651497571Halyard49757497572026-06-06
10680651497588Halyard49758497582026-06-06
10680651497595Halyard49759497592026-06-06
20680651500674Halyard50067500672026-06-04

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