FDA.reportPublic FDA data

Halyard

Primary DI
30680651474194
Brand
Halyard
Company
O&M HALYARD, INC.
Model
47419
Catalog number
47419
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
30680651474194PrimaryGS10
90680651474196Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065147419430680651474194
9068065147419690680651474196

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
20680651487616PUREZERO* MARIN* XTRA*48761487612022-06-06
20680651487623PUREZERO* MARIN* XTRA*48762487622022-06-06
20680651487630PUREZERO* MARIN* XTRA*48763487632022-06-06
20680651487647PUREZERO* MARIN* XTRA*48764487642022-06-06
20680651487654PUREZERO* MARIN* XTRA*48765487652022-06-06
20680651487661PUREZERO* MARIN*48766487662022-06-06
20680651487678PUREZERO* MARIN*48767487672022-06-06
20680651487685PUREZERO* MARIN*48768487682022-06-06
20680651487692PUREZERO* MARIN*48769487692022-06-06
20680651487708PUREZERO* MARIN*48770487702022-06-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095488INSTRUSAFESummit Medical, Inc.KCT2026-11-05
00385640095471INSTRUSAFESummit Medical, Inc.KCT2026-11-04
10886982278746NASynthes GmbHKCT2026-11-03
10886982346421NASynthes GmbHKCT2026-11-03
00385640095433INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00841536147971ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147988ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148015ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148237ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148336ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148343ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148350ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148367ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147445ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147452ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147469ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147476ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147322ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147353ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147414ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148022ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148312ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148480ThompsonThompson Surgical Instruments, Inc.KCT2026-08-12
00841536148459ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536148466ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536147162ThompsonThompson Surgical Instruments, Inc.KCT2025-12-09
00841536146516ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146523ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146875ThompsonThompson Surgical Instruments, Inc.KCT2025-08-28
00841536146912ThompsonThompson Surgical Instruments, Inc.KCT2025-07-08