FDA.reportPublic FDA data

Generic

Primary DI
D8305605102
Brand
Generic
Company
GS Medical Packaging Inc
Model
560510
Device description
TYVEK S/S POUCH 5.25" X 10"
Published
2016-10-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953829000SAFE-T-SEALGs Medical Packaging, Inc.1995-11-09KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8305605101PackageHIBCC200In Commercial Distribution
D8305605102PackageHIBCC10In Commercial Distribution
D830560510PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(514)636-6262zhusseiny@medicom.ca

Regulatory Flags#

DUNS number
246113039
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
D8305506122Tyvek Heat-Seal Pouch5506122025-01-02
D8305506752Tyvek Heat-Seal Pouch5506752025-01-02
D8305508132Tyvek Heat-Seal Pouch5508132025-01-02
D8305513230Tyvek Heat-Seal Pouch5513232025-01-02
D8305518240Tyvek Heat-Seal Pouch5518242025-01-02
D8305604092Tyvek Self-Seal Pouch5604092025-01-02
D8305605152Tyvek Self-Seal Pouch5605152025-01-02
D8305606132Tyvek Self-Seal Pouch5606132025-01-02
D8305607132Tyvek Self-Seal Pouch5607132025-01-02
D8305608162Tyvek Self-Seal Pouch5608162025-01-02
D8305610152Tyvek Self-Seal Pouch5610152025-01-02
D83050000081Element Self Sealing Sterilization Pouch500-0008500-00082020-10-15
D830500000091Element Self Sealing Sterilization Pouch500-00009500-000092020-06-08
D830500000102Element Self Sealing Sterilization Pouch500-00010500-000102019-11-18
D830500000112Element Self Sealing Sterilization Pouch500-00011 500-00011 2019-11-18
D830221632BL1STERIL PEEL221632-BL2019-10-15
D8302214330Steril Peel2214332016-10-05
D8302214341STERIL-PEEL2214342016-10-05
D830221434RX0Steril Peel221434RX 2017-02-07
D830221434RXEU0Steril Peel221434RXEU 2017-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
08404535029437Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
08404535025927Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-01
08404535015003Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535019100Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025217Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025248Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
08404535025279Brasseler USAPeter Brasseler Holdings, LLCFRG2026-04-29
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178506MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178513MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178568MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15