Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030907317

FEI Number

3030907317

Entity Name

DaklaPack US Inc.

City/State/Country

Wyckoff, NJ, US

Establishment Address

500 W Main St Ste 2, Wyckoff, NJ 07481, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DaklaPack US Inc. (Owner Number: 10093569)

Owner / Operator Contact Address

500 West Main St, suite 2, Wyckoff, NJ 07481, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240045

PMA Number

N/A

All Registered Proprietary Names

Teal Wand Vaginal Sample Self-Collection Device for Cervical Cancer Screening

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SEP	Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay	Microbiology	Class 2	866.2920	2025-06-04

Official Correspondent

Andrew Muntean

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DaklaPack US 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 3030907317. Last updated year: 2026. Please use registration number 3030907317 when referencing this establishment in official correspondence.