FDA.reportPublic FDA data

Unipack

Primary DI
D784UPP2251
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UPP-225
Catalog number
UPP-225
Device description
"Sterilization Pouches 2-1/4"" x 5"""
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
D784UPP2251PrimaryHIBCC0
D784UPP2250Unit 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
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
866-686-47224info@unipackmedical.com
+1(866)686-47224info@unipackmedical.com
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
018319397
Device count
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D784UBC80461UnipackUBC-8046UBC-80462022-12-06
D784UPST0501UnipackUPST-050UPST-0502022-12-06
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
D784UPP27101UnipackUPP-2710UPP-27102016-09-15
D784UPP27101K1UnipackUPP-2710-1KUPP-2710-1K2016-09-16
D784UPP291UnipackUPP-29UPP-292016-09-16
D784UPP32121UnipackUPP-3212UPP-32122016-09-16
D784UPP35101UnipackUPP-3510UPP-35102016-09-16
D784UPP35101K1UnipackUPP-3510-1KUPP-3510-1K2016-09-15
D784UPP35651UnipackUPP-3565UPP-35652016-09-15
D784UPP42121UnipackUPP-4212UPP-42122016-09-15
D784UPP52111UnipackUPP-5211UPP-52112016-09-15
D784UPP52751UnipackUPP-5275UPP-52752016-09-16
D784UPP75131UnipackUPP-7513UPP-75132016-09-16
00850008682216UnipackUAT-9051UAT-90512022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094795INSTRUSAFESummit Medical, Inc.KCT2026-10-06
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00385640094818INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094825INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094726INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094733INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094740INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094757INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094764INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094771INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094788INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00724995238360V. MuellerSteris CorporationKCT2026-10-05
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094696INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094702INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094719INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094658INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094665INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094672INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094580INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094597INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094603INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094610INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094627INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094634INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094641INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00850092212009SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29
00860010729267STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729274STITCH STANDContainmed, Inc.KCT2026-09-29
00860010729281SteriPod Sterilization ContainerContainmed, Inc.KCT2026-09-29