FDA.reportPublic FDA data

INTENSA

Primary DI
M368748WH1
Brand
INTENSA
Company
GF HEALTH PRODUCTS, INC.
Model
748-WH
Device description
HYDRAULIC SURGICAL STOOL
Published
2023-12-01
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
M368748WH1PrimaryHIBCC0

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
M368FR601EPCHBN04271LUMEXFR601EPCHBN-04272026-09-18
M368FR601EPCHBN96071LUMEXFR601EPCHBN-96072026-09-18
M368FR601EPCHNN04271LUMEXFR601EPCHNN-04272026-09-18
M368FR601EPCNBN04271LUMEXFR601EPCNBN-04272026-09-18
M368FR601EPCNNN04271LUMEXFR601EPCNNN-04272026-09-18
M368FR601EPCOBN04271LUMEXFR601EPCOBN-04272026-09-18
M368FR601EPCONN04271LUMEXFR601EPCONN-04272026-09-18
M368FR601EPNHBN04271LUMEXFR601EPNHBN-04272026-09-18
M368FR601EPNHNN04271LUMEXFR601EPNHNN-04272026-09-18
M368FR601EPNHNN86021LUMEXFR601EPNHNN-86022026-09-18
M368FR601EPNNBN04271LUMEXFR601EPNNBN-04272026-09-18
M368FR601EPNNBN86041LUMEXFR601EPNNBN-86042026-09-18
M368FR601EPNNNN03171LUMEXFR601EPNNNN-03172026-09-18
M368FR601EPNNNN04271LUMEXFR601EPNNNN-04272026-09-18
M368FR601EPNOBN04271LUMEXFR601EPNOBN-04272026-09-18
M368FR601EPNONN04271LUMEXFR601EPNONN-04272026-09-18
M368FR601EPNONN13111LUMEXFR601EPNONN-13112026-09-18
M368FR601EUCHBN04271LUMEXFR601EUCHBN-04272026-09-18
M368FR601EUCHNN04271LUMEXFR601EUCHNN-04272026-09-18
M368IN601EPCHBNCOM1INTENSAIN601EPCHBN-COM2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260647946109Doctor stool ak 445AKRUS GmbH & Co. KGFZM2026-06-22
04260647946116Doctor stool ak 446AKRUS GmbH & Co. KGFZM2026-06-22
04260647946123Doctor stool ak 447AKRUS GmbH & Co. KGFZM2026-06-22
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