Unipack

Irrigation Needle Tips 30G Notched Purple /Luer Lock

Registry build 21.09.26
22manufacturers in China registered for this device type
15catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Shanghai (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EIB
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Ningbo Caremed Medical Products Co Ltd Ningbo Zhejiang Contract manufacturer 6
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52
TF NEW Material SCI AND TEC Co., Ltd. Huainan Anhui Manufacturer 51
Hefei Mlush Sanitary Products Co., Ltd. Hefei Anhui Manufacturer 48
Zhejiang Medicines & Health Products I/ E Co., Ltd. Hangzhou Zhejiang Exporter 41
Shanghai Dynamic Medical Supplies Co., Ltd. Shanghai Shanghai Contract manufacturer 37
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 17

Showing 12 of 22. All 22 manufacturers in China registered for Syringe, Irrigating (Dental)

Record

Regulatory record for Unipack
Listed by Unipack LLC, United States
FDA product code EIB
Device type Syringe, Irrigating (Dental)
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2022-12-06
Record revised 2024-06-11 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Latex Contains natural rubber latex
Label carries lot or batch number
Packaging Case of 20, case of 10

Catalogue Numbers

Catalogue numbers for Unipack
Catalogue number Size Per pack Status
URN-55003-23 100 In distribution
URS-55012 100 In distribution
URN-55230 100 In distribution
URN-55227 100 In distribution
URN-55223 100 In distribution
URN-55323 100 In distribution
URN-55003-27 100 In distribution
URS-55006 100 In distribution
URS-55003 100 In distribution
URN-55103-27 100 In distribution
URN-55103-23 100 In distribution
URN-55327 100 In distribution
URN-55330 100 In distribution
URN-55003-30 100 In distribution
URN-55103-30 100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
PlastCare Proguard Health Inc. 7
Britedent Bright Supply Inc 7
House Brand Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. 4
House brand Shifeng Medical Technology Co.,ltd. 3
Safco Irrigating Syringes Safco Dental Supply 3
House Brand Dentistry Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. 3
HU-Friedy HU-Friedy MFG Co., LLC 3
Nivo B. ALI Impex 1
Advance Dental Products THE Atlanta Dental Supply Company 1
Monoject Cardinal Health 200, LLC 1
BR Surgical, LLC BR Surgical LLC 1
Safco Air/Water Syringe Tips Safco Dental Supply 1

Showing 12 of 14. All products under Syringe, Irrigating (Dental)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer