Dignitana, Inc.

FDA Device Registration & Listing · Dallas, TX, US · Registration 3012146457

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
3012146457
FEI Number
3012146457
Entity Name
Dignitana, Inc.
City/State/Country
Dallas, TX, US
Establishment Address
10925 Estate Lane, Suite W-185, Dallas, TX 75238, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Dignitana Inc (Owner Number: 10050834)
Owner / Operator Contact Address
10925 Estate LN, Suite W-185, Dallas, TX 75238, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191166
PMA Number
N/A

All Registered Proprietary Names

DigniCap Delta

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PMC Scalp Cooling System General, Plastic Surgery Class 2 878.4360 2019-08-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dignitana Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008888703 DIGNITANA AB Lund Skane, SE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012146457. Last updated year: 2026. Please use registration number 3012146457 when referencing this establishment in official correspondence.
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