FDA.report

LUMEX

Primary DI
M368GF184020
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
GF1840-2
Catalog number
GF1840-2
Device description
FT STOOL ECN BLK EPXY FIN 2/CS
Published
2021-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FZMStool, Operating-Room

Product Code Classifications

CodeDeviceSpecialtyClass
FZMStool, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M368GF184021PrimaryHIBCC0
M368GF184020Unit of UseHIBCC0

GMDN Terms

TermDefinition
FootstoolA platform, with or without legs, designed for a person to stand upon to compensate for differences in height or to place the feet/legs upon for rest/support when seated. It may be conductive to reduce the risk of static electricity when used in areas such as examination rooms or operating theatres, or non-conductive.

Sterilization Methods

Method

Contacts

PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags

DUNS number
132016168
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
M36823562X1GRAHAM FIELD2356-2X 2026-02-20
M36823572A1GRAHAM FIELD2357-2A 2026-02-20
M3682360A1GRAHAM FIELD2360A 2026-02-20
M3682362X2GRAHAM FIELD2362X2026-02-20
M368ESC2EYESTMBX1HAUSTEDESC2EYEST-MB-X2026-02-02
M368H0678972HAUSTEDH0678972025-10-31
M368ALX361AMERILUXALX362025-12-11
M368ALX421AMERILUXALX422025-12-11

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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
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04260647945768Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945775Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
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04260647945799Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28