Tepha, Incorporated

FDA Device Registration & Listing · Lexington, MA, US · Registration 3005670760

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005670760
FEI Number
3005670760
Entity Name
Tepha, Incorporated
City/State/Country
Lexington, MA, US
Establishment Address
99 Hayden Avenue, Suite 360, Lexington, MA 02421, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Tepha Inc. (Owner Number: 10023049)
Owner / Operator Contact Address
99 Hayden Ave, Suite 360, Lexington, MA 02421, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K140533
PMA Number
N/A

All Registered Proprietary Names

GalaFLEX LITE GalaFLEX 3D GalaFLEX 3DR GalaFLEX

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2024-04-25
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2016-09-13
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2017-03-29
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2015-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tepha 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 3005670760. Last updated year: 2026. Please use registration number 3005670760 when referencing this establishment in official correspondence.
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