GALDERMA LABORATORIES, L.P.

FDA Device Registration & Listing · Fort Worth, TX, US · Registration 1000118068

Public Record Device Listing Expiry Year: 2026 AvaSpecs displays structured public-record fields for easier browsing and citation.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000118068
FEI Number
1000118068
Entity Name
GALDERMA LABORATORIES, L.P.
City/State/Country
Fort Worth, TX, US
Establishment Address
14600 Heritage Pkwy, Fort Worth, TX 76177, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Galderma Laboratories, L.P. (Owner Number: 10047852)
Owner / Operator Contact Address
14600 Heritage Parkway, Fort Worth, TX 76177, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K110850
PMA Number
N/A

All Registered Proprietary Names

Terumo 27 G TW Needle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-04-23

Official Correspondent

Randy Russell

US Agent Details

No US Agent registered (Local establishment).

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000118068. Last updated year: 2026. Please use registration number 1000118068 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
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