FDA.reportPublic FDA data

Tyvek Self-Seal Pouch

Primary DI
D8305608162
Brand
Tyvek Self-Seal Pouch
Company
GS Medical Packaging Inc
Model
560816
Device description
Tyvek 8” x 16” Self-Seal Pouch
Published
2025-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141412000STERILUCENT SELF-SEAL STERILIZATION POUCHGs Medical Packaging, Inc.2014-12-03FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8305608162PackageHIBCC5In Commercial Distribution
D8305608161PrimaryHIBCC0
D8305608160Unit of UseHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246113039
Device count
200
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
true
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
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
D8302214360Steril Peel221436 2016-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091155109Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155116Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155123Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155130Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155147Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155154Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155161Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155178Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155185Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155192Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
06954454006672COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006689COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006696COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006702COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006719COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006726COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006733COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006740COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454013984COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
08404535038446Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-30
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23