Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013523368

FEI Number

3013523368

Entity Name

TALA SURGICAL, INC.

City/State/Country

Hatillo, PR, US

Establishment Address

Hc 01 Box 7268, Hatillo, PR 00659, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Tala Surgical, Inc. (Owner Number: 10054302)

Owner / Operator Contact Address

Hc 01 Box 7268, Hatillo, PR 00659, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GauzeStix intraoral gauze holder/Molar and Premolar Surgical Site GauzeStix intraoral gauze holder/Third Molar Surgical Site

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2017-03-06

Official Correspondent

Cesar Talavera

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tala Surgical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013523368. Last updated year: 2026. Please use registration number 3013523368 when referencing this establishment in official correspondence.