FDA.reportPublic FDA data

Coulmed

Primary DI
10810087352131
Brand
Coulmed
Company
Coulmed Products Group LLC
Model
168-2
Catalog number
168-2
Device description
Revolving Stool Cushion, Non-Conductive, 13' Dia., 1 Inch thick, Standard Black
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10810087352131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081008735213110810087352131

GMDN Terms#

Term, Definition table
TermDefinition
Stool cushionA soft pillow or pad used to provide support and comfort to the user while sitting on a stool. The device may also be used to elevate the user by increasing the height of the seat. This is a reusable device.

Regulatory Flags#

DUNS number
047115479
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810087352605CoulmedAC28-PAC28-P2023-01-06
10810087352612CoulmedAC3300-BPAC3300-BP2023-01-06
10810087352629CoulmedAC3400-BPAC3400-BP2023-01-06
10810087352636CoulmedAC3800-BPAC3800-BP2023-01-06
10810087352643CoulmedAC3800-BP-LAC3800-BP-L2023-01-06
10810087352650CoulmedAC3800-BP-RAC3800-BP-R2023-01-06
10810087352667CoulmedAC3900-BPAC3900-BP2023-01-06
10810087350007CoulmedDI-5403DI-54032023-01-06
10810087350014CoulmedDI-5404DI-54042023-01-06
10810087350021CoulmedDI-5406DI-54062023-01-06
10810087350038CoulmedDI-5408DI-54082023-01-06
10810087350045CoulmedDI-5414DI-54142023-01-06
10810087350052CoulmedDI-5415DI-54152023-01-06
10810087350069CoulmedDI-5416DI-54162023-01-06
10810087350076CoulmedDI-5419DI-54192023-01-06
10810087350083CoulmedDI-5420DI-54202023-01-06
10810087350090CoulmedDI-5424DI-54242023-01-06
10810087350106CoulmedDI-5503DI-55032023-01-06
10810087350113CoulmedDI-6101DI-61012023-01-06
10810087350120CoulmedDI-6102DI-61022023-01-06

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