Optomic

GUDID 08436041581130

OPTOMIC ESPAÑA SA

ENT examination/treatment system

• Primary Device ID: 08436041581130
• NIH Device Record Key: 9fe3f02d-cdd3-4fc6-b77d-74a464f5feef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optomic
• Version Model Number: OTOSMART PLUS WORKSTATION
• Company DUNS: 564165678
• Company Name: OPTOMIC ESPAÑA SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08436041581130 [Primary]

FDA Product Code

• ETF: Unit, Examining/Treatment, Ent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-26
• Device Publish Date: 2024-07-18

On-Brand Devices [Optomic]

• 08436041581352: OP-12 Microscope
• 08436041580294: OP-2000 HD Camera
• 08436041580270: OP-714 Camera
• 08436041580263: Strobolux III LED + HD Stroboscope
• 08436041580256: Strobolux III LED Stroboscope
• 08436041580164: OP-LS5 Portable LED Light Source
• 08436041580157: Fibrolux LED HP Duo Light Source
• 08436041580140: Fibrolux LED HP Light Source (Amber)
• 08436041580133: Fibrolux LED HP Light Source
• 08436041580072: OP-C16 Microscope (240)
• 08436041580065: OP-C16 Microscope
• 08436041580041: OP-DENT5 Microscope (45)
• 08436041580034: OP-DENT5 Microscope (240)
• 08436041580027: OP-DENT Microscope (45)
• 08436041580010: OP-DENT Microscope (240)
• 08436041581468: OP-S9 CHAIR (STRUCTURE)
• 08436041581451: OP-S9 CHAIR
• 08436041581178: OPTIMUS ELITE WORKSTATION
• 08436041581161: OPTIMUS EXPERT WORKSTATION
• 08436041581154: OTOSMART COMPACT S WORKSTATION
• 08436041581147: OTOSMART COMPACT WORKSTATION
• 08436041581130: OTOSMART PLUS WORKSTATION
• 08436041581123: OTOSMART WORKSTATION
• 08436041581116: OPTIMUS WORKSTATION
• 08436041580690: OP-G7+N CHAIR (FOOT SUPPORTS)
• 08436041580683: OP-G7+N CHAIR (GOEPEL)
• 08436041580676: LARYNGOSCOPE OPT 10mm x 158mm x 90 AUT
• 08436041580669: LARYNGOSCOPE OPT 10mm x 158mm x 70 AUT
• 08436041580638: LARYNGOSCOPE OPT 6mm x 158mm x 70 AUT
• 08436041580621: MICRO LARYNGOSCOPE OPT 4mm x 185mm x 70 AUT
• 08436041580614: OTOSCOPE OPT 4mm x 50mm x 30
• 08436041580607: OTOSCOPE OPT 4mm x 50mm x 0
• 08436041580591: OTOSCOPE OPT 2,7mm x 75mm x 70 AUT.
• 08436041580584: OTOSCOPE OPT 2,7mm x 75mm x 30 AUT.
• 08436041580577: OTOSCOPE OPT 2,7mm x 75mm x 0 AUT.
• 08436041580539: OTOSCOPE OPT 1,9mm x 100mm x 30 AUT.
• 08436041580522: OTOSCOPE OPT 1,9mm x 100mm x 0 AUT.
• 08436041580478: OP-G7+ CHAIR (FOOT SUPPORTS)
• 08436041580461: OP-G7+ CHAIR (GOEPEL)
• 08436041580454: OP-S4 CHAIR (STRUCTURE)
• 08436041580447: OP-S7 CHAIR (STRUCTURE)
• 08436041580430: OP-S6 CHAIR (STRUCTURE)
• 08436041580423: OP-S8 CHAIR (STRUCTURE)
• 08436041580416: OP-S10 CHAIR (STRUCTURE)
• 08436041580409: OP-S4 CHAIR
• 08436041580393: OP-S7 CHAIR
• 08436041580386: OP-S6 CHAIR
• 08436041580379: OP-S8 CHAIR
• 08436041580362: OP-S10 CHAIR
• 08436041580126: OP-C2 COLPOSCOPE