FDA.reportPublic FDA data

Moore Medical

Primary DI
20607415000058
Brand
Moore Medical
Company
MOORE MEDICAL LLC
Model
12844
Device description
Sterilization Pouch 7.5x13
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941327000CROSSTEX SELF-SEALING STERILIZATION POUCHCross Country Paper Products Corp.1994-12-22KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40607415000069PackageGS110In Commercial Distribution
20607415000058PrimaryGS10
10607415003939Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4060741500006940607415000069
2060741500005820607415000058
1060741500393910607415003939

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
051420107
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607415001850Moore Medical932642016-12-09
10607415001874Moore Medical932672016-12-09
10607415001898Moore Medical932632016-12-09
10607415001911Moore Medical932662016-12-09
10607415001935Moore Medical932682016-12-09
10607415001959Moore Medical93269 2016-12-09
10607415001973Moore Medical932702016-12-09
10607415003656Moore Medical932652016-12-09
20607415000072Moore Medical827902016-12-09
20607415000096Moore Medical827912016-12-09
20607415000119Moore Medical827892016-12-09
10607415001614Moore Medical830302016-12-09
20607415001314Moore Medical137842016-12-09
20607415000010Moore Medical128422016-12-09
20607415000034Moore Medical128432016-12-09
10607415001294Moore Medical137862016-12-09
10607415002055Moore Medical306442016-12-09
10607415002062Moore Medical306492016-12-09
10607415001997Moore Medical141702016-12-09
10607415002000Moore Medical141712016-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00385640092456INSTRUSAFESummit Medical, Inc.KCT2026-08-07