FDA.reportPublic FDA data

Unipack

Primary DI
D784UBC855001
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UBC-85500
Catalog number
UBC-85500
Device description
"Evacuation Traps 85500 Diameter 1-1/4"""
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHZEvacuator, oral cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D784UBC855005PackageHIBCC8In Commercial Distribution
D784UBC855001PrimaryHIBCC0
D784UBC855000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system in-line filterA screening device designed to be fitted in the suction line of a dental suction system (e.g., in the saliva ejector valve) to trap debris [e.g., amalgam, bone particles, dentin/enamel particles] and stop them from entering the mains drainage system during a dental procedure. It is in the form of cylindrical/conical flange with numerous small openings. The device is not intended to be used as a dedicated autologous bone particle collector. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
018319397
Device count
144
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
D955IRRTIP1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKO1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOT1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOTS1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOWT1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
00810194403187AiraAIRA, LLCEHZ2026-08-26
00810194403231AiraAIRA, LLCEHZ2026-08-26
00810194403248AiraAIRA, LLCEHZ2026-08-26
00814005020006TAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502001315P2-90AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502003703BATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502005115P3AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502006803BAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502008202BAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502009946P3MQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502010515P2ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502013615P2AQUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020143FR3QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020174FR15P2QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020181FR2QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020198FR4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502020446P3ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502021115P2-1/4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502022815P3-1/4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502023556P2QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502024256P3QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502026615P3HOQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502027315P3ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502028015P1AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502030316RSAQUALITY ASPIRATORS, INC.EHZ2025-02-27