FDA.reportPublic FDA data

Unipack

Primary DI
00850008682360
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UAT-9053
Catalog number
UAT-9053
Device description
COLOR-BRITE Air/Water Tips
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
ECBUNIT, SYRINGE, AIR AND/OR WATER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850008682367PackageGS116In Commercial Distribution
00850008682360PrimaryGS10
20850008682364Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000868236710850008682367
00850008682360008500086823608500086823600850008682360
2085000868236420850008682364

Contacts#

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

Regulatory Flags#

DUNS number
018319397
Device count
250
Premarket exempt
true
Lot or batch
true
No natural rubber latex
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
06954454001882COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-31
06954454001875COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013465COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013472COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013571COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013908COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454013915COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454014363COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454014707COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454014714COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454014745COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454016060COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454016077COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454016084COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
06954454016091COTISENHuanghua Promisee Dental Co., Ltd.ECB2026-10-27
00810194402845AiraAIRA, LLCECB2026-08-26
00810194402852AiraAIRA, LLCECB2026-08-26
00810194402876AiraAIRA, LLCECB2026-08-26
00810194402883AiraAIRA, LLCECB2026-08-26
00810194402890AiraAIRA, LLCECB2026-08-26
00840456224465JMUJMU DENTAL, INCECB2026-07-24
00810230800116DCI PartsDCI International, LLCECB2026-06-26
00810230800123DCI PartsDCI International, LLCECB2026-06-26
00810230800130DCI PartsDCI International, LLCECB2026-06-26
00810230800147DCI PartsDCI International, LLCECB2026-06-26
00810230800154DCI PartsDCI International, LLCECB2026-06-26
00810230800161DCI PartsDCI International, LLCECB2026-06-26
00810230800178DCI PartsDCI International, LLCECB2026-06-26
00810230800185DCI PartsDCI International, LLCECB2026-06-26
00810230800192DCI PartsDCI International, LLCECB2026-06-26