FDA.reportPublic FDA data

Maytex Nupack

Primary DI
D806STP35101001
Brand
Maytex Nupack
Company
MAYTEX CORPORATION
Model
STP3510-100
Device description
"See Through Sterilization pouch 3 1/2"" x 10"""
Published
2019-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K162258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162258000Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd.2017-04-28FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D806STP35101001PrimaryHIBCC0
D806STP35101000Unit of UseHIBCC0

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
196642151
Device count
100
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8063145BL1Cool Breathe3145BL2024-06-11
D8066050B1Maytex6050B2024-06-11
D8063145BL0Cool Breathe3145BL2024-06-11
D8066050B0Maytex6050B2024-06-11
D806OSI5324132MIZUHO OSI OSI5324-132016-09-23
D806OSI581212MIZUHO OSI OSI5812-12016-09-23
D806OSI5817122MIZUHO OSIOSI5817-122016-09-23
D806OSI5844112MIZUHO OSI OSI5844-112016-09-23
D806OSI5844122MIZUHO OSI OSI5844-122016-09-23
D806OSI94112MIZUHO OSIOSI941-12016-09-23
D8066050BXL1Maytex6050BXL2024-06-10
D8066250TL1Maytex6250T-L2024-06-10
D8066250TM1Maytex6250T-M2024-06-10
D8066250TS1Maytex6250T-S2024-06-10
D8066250TXL1Maytex6250T-XL2024-06-10
D8066050BXL0Maytex6050BXL2024-06-10
D8066250TL0Maytex6250T-L2024-06-10
D8066250TM0Maytex6250T-M2024-06-10
D8066250TS0Maytex6250T-S2024-06-10
D8066250TXL0Maytex6250T-XL2024-06-10

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Primary DI, Brand, Company table
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00385640094627INSTRUSAFESummit Medical, Inc.KCT2026-09-29