FDA.reportPublic FDA data

Unipack

Primary DI
10665973030491
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
URS-55003
Catalog number
URS-55003
Device description
Irrigation Syringes Luer Lock 3cc
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
EIBSyringe, irrigating (dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIBSyringe, Irrigating (Dental)Dental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40665973030492PackageGS110In Commercial Distribution
10665973030491PrimaryGS10
00665973030494Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4066597303049240665973030492
1066597303049110665973030491
00665973030494006659730304946659730304940665973030494

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
018319397
Device count
100
Premarket exempt
true
Lot or batch
true
Contains 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
20192253068877MonojectCardinal Health 200, LLCEIB2026-01-29
50192253068878MonojectCardinal Health 200, LLCEIB2026-01-29
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G001HSB1071150House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
G001HSB1071190House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
G001HSB1072000House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
00840183524234BR Surgical, LLCBR Surgical, LLCEIB2024-06-10
D974BSI10191BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10211BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10251BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10190BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10210BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10250BritedentBright Supply, Inc.EIB2024-06-07
G001HSB1071140House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071151House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1072001House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071141House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071152House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1072002House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
D974BSI10181BritedentBright Supply, Inc.EIB2024-04-08
D974BSI10180BritedentBright Supply, Inc.EIB2024-04-08
08964003163785Doctor NiceB. Ali ImpexEIB2024-01-29
08964003163433NivoB. Ali ImpexEIB2024-01-27
G002HSB107110House brand SHIFENG MEDICAL TECHNOLOGY CO.，LTD.EIB2023-05-10
10850002458166Advance Dental ProductsThe Atlanta Dental Supply CompanyEIB2023-02-10
20850002458163Advance Dental ProductsThe Atlanta Dental Supply CompanyEIB2023-02-10
10665973030507UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
10665973030514UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
D784URN55003231UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
D784URN55003271UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06