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Barrigel® Applicator Needle - HSA Registration DE0509353

Access comprehensive regulatory information for Barrigel® Applicator Needle in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509353 and owned by Pallete Life Sciences. The device was registered on June 05, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0509353
Barrigel® Applicator Needle
HSA Registration Number: DE0509353
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Product Description

The Barrigel Applicator Needle is designed for injection of Barrigel. The patient contacting portion of the needle is silicone coated, 304 stainless steel. Gamma irradiation is used to sterilize the needle. The Barrigel Applicator Needle is provided in a pouch with two needles.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509353
Registration Date
June 05, 2024
Retention Due Date
June 04, 2025
Product Owner
Short Name
Pallete Life Sciences
Address
27 East Cota St., Suite 402, Santa Barbara, California, 93101, UNITED STATES
Registrant
Address
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Importer
Address
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
Barrigel® Applicator Needle 3ml
Model Identifier(s)
3009-2