FDA.reportPublic FDA data

Unipack

Primary DI
D784UBC8012B1
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UBC-8012B
Catalog number
UBC-8012B
Device description
"Tray Sleeves B-Tray 10 1/2"" x 14"""
Published
2022-12-07
Public version status
New
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
NRDUnit, operative dental, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D784UBC8012B5PackageHIBCC6In Commercial Distribution
D784UBC8012B1PrimaryHIBCC0
D784UBC8012B0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray cover, single-useA flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
018319397
Device count
500
Premarket exempt
true
Lot or batch
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
D784UPP2251UnipackUPP-225UPP-2252016-09-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
04719965090013INTRAORAL CAMERACHUAN FU MEDICAL INSTRUMENT CO., LTD.NRD2026-10-22
06954454006757COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006764COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006771COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006788COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006795COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006801COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006818COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006825COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006832COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454013991COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014004COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014011COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014028COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014035COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
D832SPD05081PlasdentPLASDENT CORPORATIONNRD2026-07-20
00840456223246JMUJMU DENTAL, INCNRD2026-07-08
00840456223253JMUJMU DENTAL, INCNRD2026-07-08
00840456223260JMUJMU DENTAL, INCNRD2026-07-08
00840456223277JMUJMU DENTAL, INCNRD2026-07-08