FDA.reportPublic FDA data

Unipack

Primary DI
D784UPST0501
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UPST-050
Catalog number
UPST-050
Device description
"Sterilization Tape Steam 1/2"" x 60 yards"
Published
2022-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993764000MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCHMedipack Medical Packaging Mfg. Co.1999-12-16KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D784UPST0505PackageHIBCC6In Commercial Distribution
D784UPST0501PrimaryHIBCC0
D784UPST0500Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
018319397
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973029839UnipackUGC-6610-LUGC-6610-L2022-12-06
10665973029846UnipackUGC-6610-MUGC-6610-M2022-12-06
10665973029853UnipackUGC-6610-SUGC-6610-S2022-12-06
10665973029860UnipackUGC-6610-XLUGC-6610-XL2022-12-06
10665973029877UnipackUGC-6610-XXLUGC-6610-XXL2022-12-06
10665973030347UnipackUGJ-6510-LUGJ-6510-L2022-12-06
10665973030354UnipackUGJ-6510-MUGJ-6510-M2022-12-06
10665973030361UnipackUGJ-6510-SUGJ-6510-S2022-12-06
10665973030378UnipackUGJ-6510-XLUGJ-6510-XL2022-12-06
10665973030385UnipackUGJ-6510-XXLUGJ-6510-XXL2022-12-06
D784UPST0751UnipackUPST-075UPST-0752022-12-06
D784UPST1001UnipackUPST-100UPST-1002022-12-06
D784UZM30011UnipackUZM-3001UZM-30012022-12-06
D784UPP10151UnipackUPP-1015UPP-10152016-09-15
D784UPP12181UnipackUPP-1218UPP-12182016-09-16
D784UPP2231UnipackUPP-223UPP-2232016-09-15
D784UPP2251UnipackUPP-225UPP-2252016-09-15
D784UPP27101UnipackUPP-2710UPP-27102016-09-15
D784UPP27101K1UnipackUPP-2710-1KUPP-2710-1K2016-09-16
D784UPP291UnipackUPP-29UPP-292016-09-16

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
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
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
10197344178629MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178650MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178667MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178698MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177950MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177967MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15