FDA.reportPublic FDA data

S4Optik

Primary DI
00628308210596
Brand
S4Optik
Company
INNOVA Medical Ophthalmics Inc
Model
ST1S4-348-000
Device description
Exam office stool without backrest ST1S4-348-000
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00628308210596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628308210596006283082105966283082105960628308210596

Regulatory Flags#

DUNS number
243325332
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628308210565S4OptikTA1S4-346-0002026-11-03
00628308210589S4OptikST1S4-344-0002026-11-03
00628308210435S4OptikTA1-550-NA2026-03-31
00628308210459S4OptikTA1-552-NA2026-03-31
00628308210473S4OptikRT-600-SN-GRY2026-03-31
00628308210480LombartRT-600-LN-GRY2026-03-31
00628308210497S4OptikRT-600-SN-BLK2026-03-31
00628308210503LombartRT-600-LN-BLK2026-03-31
00628308210510S4OptikRT-600-SP-BLK2026-03-31
00628308210527LombartRT-600-LP-BLK2026-03-31
00628308210534LombartPD-12026-03-31
00628308210541S4OptikPD-12026-03-31
00628308210558PD-1PD-12026-03-31
00628308210336S4 OPTIKTA1INTT-36172025-08-21
00628308210343S4 OPTIKTA1INTT-2E2025-08-21
00628308210350S4 OPTIKTA1INTT-12025-08-21
00628308210367S4 OPTIK400-1002025-08-21
00628308210374S4 OPTIK222-0012025-08-21
00628308210381S4 OPTIK280-0002025-08-21
00628308210398S4 OPTIK281-0002025-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628308210589S4OptikINNOVA Medical Ophthalmics IncFZM2026-11-03
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