FDA.reportPublic FDA data

Generic

Primary DI
D8305514380
Brand
Generic
Company
GS Medical Packaging Inc
Model
551438
Device description
TYVEK ROLL 8" X 100'
Published
2016-10-06
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
D8305514380PackageHIBCC1In Commercial Distribution
D830551438PrimaryHIBCC0

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
9052711523accounting@gsmedicalpackaging.com
+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

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Primary DI, Brand, Company table
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00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
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00840456202975JMUJMU DENTAL, INCFRG2026-06-05
00840456202982JMUJMU DENTAL, INCFRG2026-06-05