FDA.reportPublic FDA data

Tyvek Heat-Seal Pouch

Primary DI
D8305506122
Brand
Tyvek Heat-Seal Pouch
Company
GS Medical Packaging Inc
Model
550612
Device description
Tyvek 6” x 12” Heat-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
D8305506122PackageHIBCC5In Commercial Distribution
D8305506121PrimaryHIBCC0
D8305506120Unit 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
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
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
D8302214360Steril Peel221436 2016-10-06

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Primary DI, Brand, Company table
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20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
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