FDA.reportPublic FDA data

Optomic

Primary DI
08436041580447
Brand
Optomic
Company
OPTOMIC ESPAÑA SA
Model
OP-S7 CHAIR (STRUCTURE)
Published
2024-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GBBChair, Surgical, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBBChair, Surgical, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436041580447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436041580447084360415804478436041580447

GMDN Terms#

Term, Definition table
TermDefinition
ENT chair, electricA mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate ear, nose, throat (i.e., ENT) examination, treatment, and/or minor surgery. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to standard positions. Devices intended for ENT examination and/or treatment (e.g., otoscopes, laryngoscopes) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
564165678
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436041580485OptomicOP-30 Naso-pharyngoscope2024-08-01
08436041580089OptomicOP-C12 COLPOSCOPE (45) 2024-07-18
08436041580096OptomicOP-C16 COLPOSCOPE (45) 2024-07-18
08436041580102OptomicOP-C5 COLPOSCOPE 2024-07-18
08436041580119OptomicOP-C2L COLPOSCOPE 2024-07-18
08436041580126OptomicOP-C2 COLPOSCOPE 2024-07-18
08436041580362OptomicOP-S10 CHAIR 2024-07-18
08436041580379OptomicOP-S8 CHAIR 2024-07-18
08436041580386OptomicOP-S6 CHAIR 2024-07-18
08436041580393OptomicOP-S7 CHAIR 2024-07-18
08436041580409OptomicOP-S4 CHAIR 2024-07-18
08436041580416OptomicOP-S10 CHAIR (STRUCTURE) 2024-07-18
08436041580423OptomicOP-S8 CHAIR (STRUCTURE)2024-07-18
08436041580430OptomicOP-S6 CHAIR (STRUCTURE) 2024-07-18
08436041580454OptomicOP-S4 CHAIR (STRUCTURE)2024-07-18
08436041580461OptomicOP-G7+ CHAIR (GOEPEL) 2024-07-18
08436041580478OptomicOP-G7+ CHAIR (FOOT SUPPORTS) 2024-07-18
08436041580522OptomicOTOSCOPE OPT 1,9mm x 100mm x 0 AUT.2024-07-18
08436041580539OptomicOTOSCOPE OPT 1,9mm x 100mm x 30 AUT.2024-07-18
08436041580577OptomicOTOSCOPE OPT 2,7mm x 75mm x 0 AUT.2024-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600155032011DexorRappo Robotics, Inc.GBB2026-05-16
M368EPC500ST1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-04-09
M368EPC500STMB1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-04-09
05999569240048Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569240079Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569242202Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569242219Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569244213Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569245005DiacareDIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
07350136560217Pedal platformRini Ergoteknik ABGBB2026-03-24
M368ESC2EYESTMBX1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-02-02
04049199006277SCHMITZSCHMITZ medical GmbHGBB2025-09-17
04049199006284SCHMITZSCHMITZ medical GmbHGBB2025-09-17
04049199006291SCHMITZSCHMITZ medical GmbHGBB2025-09-17
M368ESC2EYESTMB1HaustedGF HEALTH PRODUCTS, INC.GBB2025-08-21
04049199011608SCHMITZSCHMITZ medical GmbHGBB2025-08-14
00840183530372BR Surgical, LLCBR Surgical, LLCGBB2025-07-16
00840183530389BR Surgical, LLCBR Surgical, LLCGBB2025-07-16
00841709122958MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122965MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122972MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122989MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122996MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123009MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123016MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123023MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123030MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123047MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123054MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123061MidmarkMIDMARK CORPORATIONGBB2025-06-04