FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040061807
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700673
Catalog number
5700673
Device description
ProRepair Sterilization Pouch 3.5" x 9"
Published
2017-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040061807PrimaryGS10
00304040061800Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404006180710304040061807
00304040061800003040400618003040400618000304040061800

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403049ActivSight Imaging Module Clean and Disinfect TrayActiv Surgical, Inc.KCT2026-05-26
00850016403063ActivSight Light Cable Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00850016403070ActivSight Imaging Module Tray for VHPActiv Surgical, Inc.KCT2026-05-26
00850016403193ActivSight Laparoscope Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00857387006534Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
00857387006541Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
00385640091183INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091190INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091206INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091152INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00385640091169INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00385640091176INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00199150051212Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00763000710194Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00199150015429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00199150015436CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869069CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869076CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869090CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869106CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869892CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869908CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869915CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869922CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869939CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00385640091114INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091121INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091138INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091145INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00653159013232CASE MEDICALCase Medical Inc.KCT2026-03-20