Silicone T-Tube

10 Fr. x 12 in L

Registry build 21.09.26
1manufacturer
11catalogue numbers in this listing

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code PTT
Manufacturer City Province Registered as Device types
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20

Record

Regulatory record for Silicone T-Tube
Listed by Bentec Medical OpCo, LLC., United States
FDA product code PTT
Device type Biliary Catheter For Irrigation And Contrast Injection, Exempt
Device class Class 2
Regulation 21 CFR 876.5010
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-10-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Silicone T-Tube
Catalogue number Size Status
SU130-1204 In distribution
SU130-1208 In distribution
SU130-1228 In distribution
SU130-1212 In distribution
SU130-1239 In distribution
SU130-1216 In distribution
SU130-1200 In distribution
SU130-1224 In distribution
SU130-1240 In distribution
SU130-1220 In distribution
SU130-1238 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bard® T-Tube C.R. Bard, Inc. 4

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