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

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system irrigation handpiece tipA rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30810021439403DCIDCI International, LLCECB2025-11-19
00840326423677AstekYoung Innovations, Inc.ECB2025-02-07
TQ26SYT253721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.ECB2024-12-09
D248B16201DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16211DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B1629C1Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
00810339031176SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031251SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031374SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003577SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003607SAFE DENTBGSS Company Inc.ECB2024-05-01
00840326421994AstekYoung Innovations, Inc.ECB2023-12-01
00840326422007AstekYoung Innovations, Inc.ECB2023-12-01
00840326422014AstekYoung Innovations, Inc.ECB2023-12-01
00840326422021AstekYoung Innovations, Inc.ECB2023-12-01
00840326422045AstekYoung Innovations, Inc.ECB2023-12-01
00840326422052AstekYoung Innovations, Inc.ECB2023-12-01
00840326422069AstekYoung Innovations, Inc.ECB2023-12-01
00840326422076AstekYoung Innovations, Inc.ECB2023-12-01
00840326422083AstekYoung Innovations, Inc.ECB2023-12-01
00840326422090AstekYoung Innovations, Inc.ECB2023-12-01
00840326422106AstekYoung Innovations, Inc.ECB2023-12-01
00840326422113AstekYoung Innovations, Inc.ECB2023-12-01
D248B16291Uni-Tip -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16311Access-Tips -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16331Uni-Tip -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16341Access-Tips -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16351Uni-Tip -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16361Access-Tips -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248BOA124P10001Uni-Tip -Package of 5HAGER WORLDWIDE, INC.ECB2023-09-12