FDA.reportPublic FDA data

Tyvek Heat-Seal Pouch

Primary DI
D8305518242
Brand
Tyvek Heat-Seal Pouch
Company
AMD Medicom Inc
Model
551824
Device description
Tyvek 18” x 24” Heat-Seal Pouch
Published
2025-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8305518242PrimaryHIBCC0
D8305518240Unit 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.

Regulatory Flags#

DUNS number
256880576
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864061936MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
10686864061943MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
20686864061933MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
10686864060946MEDICOM DENTICARE 10067100672026-02-25
10686864060953MEDICOM DENTICARE 10068100682026-02-25
20686864060943MEDICOM DENTICARE 10067100672026-02-25
20686864060950MEDICOM DENTICARE 10068100682026-02-25
D8304405061PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514331MEDICOM5514335514332026-02-10
D8304405062PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514332MEDICOM5514335514332026-02-10
D830551432Generic5514322016-10-06
D830551434Generic5514342016-10-06
D830551436Generic5514362016-10-06
D830551438Generic5514382016-10-06
D830551440Generic5514402016-10-06
D830551442Generic5514422016-10-06
D8305604091Tyvek Self-Seal Pouch5604092025-01-02
D830560510Generic5605102016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535029437Brasseler USAPeter Brasseler Holdings, LLCFRG2026-05-13
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
10197344140008MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140015MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344140022MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149018MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149025MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10197344149032MEDLINEMEDLINE INDUSTRIES, INC.FRG2025-08-14
10198459366277MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FRG2025-06-16
10197344695331MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695348MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695355MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695362MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10197344695379MEDLINEMEDLINE INDUSTRIES, INC.FRG2024-09-26
10304040172046Henry ScheinHENRY SCHEIN, INC.FRG2023-09-08
10304040172053Henry ScheinHENRY SCHEIN, INC.FRG2023-09-08
10686864044786Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044793Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044809Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044816Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044823Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044830Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
10686864044847Medicom SafeBasicsAMD Medicom IncFRG2023-04-04
H66810503101PrehmaKeystone IndustriesFRG2023-02-20
H66810504101PrehmaKeystone IndustriesFRG2023-02-20