Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010890274

FEI Number

3010890274

Entity Name

Gabriel Scientific OU

City/State/Country

Parnu linn Parnumaa, EE

Establishment Address

Mauri tee 3, Papsaare kula, Parnu linn Parnumaa 88317, EE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Gabriel Scientific OU (Owner Number: 10046488)

Owner / Operator Contact Address

Mauri tee 3, Parnu, EE-67 88317, EE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Spry, SleepAngel soft surfaces Operating Table Medical Device Pads for (TruSystem, PST) Operating Table Medical Device Pads for (TruSystem, PST)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2014-03-27
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2021-10-29
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2021-10-29

Official Correspondent

Lyane Lind

US Agent Details

Evan Dale Business: GREENWOOD MARKETING Email: evand@sprytx.com Phone: (317) 3081945

Related Public Records

Same Entity

Gabriel Scientific OU

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2017	Trumpf Medical Systems, Inc.	1	Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Z-0041-2017	Trumpf Medical Systems, Inc.	1	Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0042-2017	Trumpf Medical Systems, Inc.	1	Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0043-2017	Trumpf Medical Systems, Inc.	1	Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system

Similar Registrations

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3033883981	NINGBO JIAQI APPAREL CO., LTD	Ningbo Zhejiang, CN
2031723	SIGMA SUPPLY & DISTRIBUTION, INC.	GLENDALE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010890274. Last updated year: 2026. Please use registration number 3010890274 when referencing this establishment in official correspondence.