FDA.reportPublic FDA data

INTENSA

Primary DI
M368748NA1
Brand
INTENSA
Company
GF HEALTH PRODUCTS, INC.
Model
748-NA
Device description
HYDRAULIC SURGICAL STOOL
Published
2023-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZMStool, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZMStool, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368748NA1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Operating room stoolA seat, usually padded and height-adjustable, intended to be occupied by operating room (OR) staff during surgical procedures as an alternative to standing; it does not include support for the back or arms. It is intended to be used in operating theatres or clean-rooms and is therefore constructed so that it is easy to clean to help minimize risk of contamination.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7703684700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057027171257UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027349366UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027753217UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027768129UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027777473UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027896099UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027924617UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027958162UFSK-OSYS Transport- and relaxing chairUFSK-International OSYS GmbHFZM2026-03-02
04260647945492Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945508Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945522Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945546Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945553Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945577Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945584Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945591Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945607Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945652Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945669Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945676Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945683Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945690Doctor stool ak 446AKRUS GmbH & Co. KGFZM2025-11-28
04260647945713Doctor stool ak 446AKRUS GmbH & Co. KGFZM2025-11-28
04260647945720Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945737Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945751Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945768Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945775Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945782Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945799Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28