Oertli®

GUDID 07630003913781

CONTINUOUS FLOW-CUTTER,; TWINAC, 20G;

Oertli-Instrumente AG

Vitrectomy system micro-cutting unit

• Primary Device ID: 07630003913781
• NIH Device Record Key: 974bebae-035c-4989-b871-7d6d5a844ac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oertli®
• Version Model Number: VV104110
• Company DUNS: 481505238
• Company Name: Oertli-Instrumente AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com
• Phone: +41717474200
• Email: quality@oertli-instruments.com

Device Dimensions

• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630003912319 [Primary]
GS1	07630003913781 [Package]; Contains: 07630003912319; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133562

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-02
• Device Publish Date: 2020-06-24

On-Brand Devices [Oertli®]

• 07630003909685: I/A TUBING SYSTEM FOR FAROS/; CR3/SWISSTECH, INCL. INFUSION; SET, DRAINAGE BAG, PE-BAG
• 07630003910735: EASYTIP 2.2MM 15°; 1 SLEEVE, 1 TESTCHAMBER
• 07630003910704: TITANSPITZE EASYTIP 2.2MM 15°; PHACO TIP EASYTIP 2.2MM 15°; POINTE PHACO EASYTIP 2.2MM 15°
• 07630003910452: CATARHEX 3 LINEAR PEDAL; CATARHEX 3 LINEAR PEDAL; CATARHEX 3 PÉDALE LINÉAIRE
• 07630003910445: CATARHEX 3 PHAKO GERÄT; CATARHEX 3 PHACO UNIT; CATARHEX 3 APPAREIL PHACO
• 07630003910315: TITANSPITZE EASYTIP 2.2MM 30°; PHACO TIP EASYTIP 2.2MM 30°; POINTE PHACO EASYTIP 2.2MM 30°
• 07630003910292: PHACO TIP EASYTIP CO-MICS 30°; 1 SLEEVE/ 1 TESTCHAMBER
• 07630003910223: EASYTIP 2.2MM 30°; 1 SLEEVE, 1 TESTCHAMBER
• 07630003910001: IRRIGATIONSAUFSATZ EASY 2.8MM; IRRIGATION-SLEEVE EASY TIP 2.8; MANCHON IRRIGATION EASY 2.8
• 07630003909982: IRRIGATIONSAUFSATZ EASY COMICS; IRRIGATION SLEEVE CO-MICS TIP; MANCHON IRRIGATION CO-MICS
• 07630003909968: EASYTIP 2.8 MM 30°; EMERGENCY KEY, 1 SLEEVE; 1 TEST CHAMBER,
• 07630003909906: TITANSPITZE EASYTIP 2.8 MM 30°; PHACO TIP EASYTIP 2.8 MM 30°; POINTE PHACO EASYTIP 2.8MM 30°
• 07630003909371: PHACO SPITZE/TIP/POINTE; EASYTIP CO-MICS 30°
• 07630003908992: TITANSPITZE EASYTIP 2.2MM 40°; PHACO TIP EASYTIP 2.2MM 40°; POINTE PHACO EASYTIP 2.2MM 40°
• 07630003908879: EASYTIP 2.2MM 40°; 1 SLEEVE, 1 TESTCHAMBER
• 07630003908855: PHACO TIP EXCELLERATOR 2. 30°; SLEEVE, TEST CHAMBER
• 07630003907636: PHAKOSET / KIT PHACO COMICS; 1 SLEEVE 1 TESTCHAMBER; 1 MANCHON, 1 CHAMBRE TEST
• 07630003907612: PHAKOSET / KIT PHACO 20G; 1 SLEEVE 1 TESTCHAMBER; 1 MANCHON, 1 CHAMBRE TEST
• 07630003905618: PHACO TIP EASYTIPCO-MICS 53°; 1 SLEEVE/ 1 TESTCHAMBER
• 07630003905533: TESTKAMMER FÜR PHAKO; TEST CHAMBER FOR PHACO; CHAMBRE TEST PHACO
• 07630003905526: PHACO SPITZE/TIP/POINTE; easyTip CO-MICS 53°
• 07630003904284: IRRIGATIONSAUFSATZ EASYTIP 2.2; IRRIGATION SLEEVE EASYTIP 2.2; MANCHON IRRIGATION EASYTIP 2.2
• 07630003904239: PHAKOSET / KIT PHACO 19G; 1 SLEEVE, 1 TESTCHAMBER; 1 MANCHON, 1 CHAMBRE TEST
• 07630003903874: SPS TWINAC; VITRECTOMY CUTTER, 23G
• 07630003903867: SPS TWINAC; VITRECTOMY CUTTER, 25G
• 07630003903829: SPS TWINAC; VITRECTOMY CUTTER, 20G
• 07630003902211: U/S PHAKO-HANDSTUECK HEXADISQ; U/S PHACO-HANDPIECE HEXADISQ; PIECE A MAIN PHACO HEXADISQ
• 07630003901832: STERILISATIONSBEHÄLTER/ABLAGE; STERILIZATION CONTAINER/TRAY; BOÎTE STERILISATION/PLATEAU
• 07630003901597: "STERILE TOUCH" AUTOCLAVABLE; FÜR/FOR/POUR STERILE BEDIENUNG; STERILE/OPERATION OS3/CATARHEX
• 07630003901382: CATARHEX TRAG-KOFFER ; CATARHEX CARRYING CASE; CATARHEX VALISE "PILOTE"
• 07630003901368: CATARHEX INSTRUMENTEN-ABLAGE ; CATARHEX INSTRUMENT-TRAY; CATARHEX PLATEAU D'INSTRUMENTS
• 07630003901351: CATARHEX INFUSIONS-STÄNDER ; CATARHEX INFUSION-TROLLEY; CATARHEX CONSOLE-MOBILE
• 07630003901337: SCHLÜSSEL FÜR PHAKO-SPITZEN ; KEY FOR PHACO-TIPS, TITANO; CLEF POUR POINTE PHACO
• 07630003900514: KAPSULOTOMIE-SPITZE, FIMOSIS; CAPSULOTOMY PLUG-ON-TIP; POINTE CAPSULOTOMIE
• 07630003900477: KAPSULOTOMIE-SPITZE, STANDARD; CAPSULOTOMY PLUG REGULAR; POINTE CAPSULOTOMIE NORMALE
• 07630003900439: DIATHERMIE-SPITZE, ANGESCHRÄGT; DIATHERMY TIP ERASER, BEVELLED; POINTE DIATHERMIE BOUT PLAT
• 07630003900415: DATHERMIE HANDSTUECK KURZ; DIATHERMY HANDPIECE SHORT; MANCHE COURT POUR POINTES DIA
• 07630003900408: DIATHERMIE HANDSTÜCK LANG; PLUG-ON DIATHERMIY; HAND PIECE LONG/ MANCHE LONGUE
• 07630003904390: I/A TUBING SYSTEM FOR FAROS/; CR3/SWISSTECH
• 07630003910988: I/A QUICKTIP, SLEEVE, 45°,; OPENING 0.25MM, LEG LENGTH; 1.2MM, INCISIONS 1.6-1.8MM
• 07630003910971: I/A QUICKTIP, SLEEVE, 45°,; OPENING 0.25MM, LEG LENGTH; 2.1MM, INCISIONS 2.2-3.2MM
• 07630003910964: I/A QUICKTIP, SLEEVE, 45°,; OPENING 0.25MM, LEG LENGTH; 1.5MM, INCISIONS 2.2-3.2MM
• 07630003904789: I/A BIMANUELL SET STERIL; I/A BIMANUAL SET STERILE; SET I/A BIMANUEL STERILE
• 07630003901177: ASPIRATION SPITZE/TIP/POINTE; "QUICK TIP" 45° 0.35MM; ÖFFNUNG/APERTURE/ORIFICE
• 07630003901160: ASPIRATION SPITZE/POINTE 45°; "QUICK-TIP"; 0.3MM ÖFFNUNG/APERTURE/ORIFICE
• 07630003901146: I/A SPITZE/TIP/POINTE; GERADE/STRAIGHT/DROITE 0.35MM; ÖFFNUNG/APERTURE/ORIFICE
• 07630003901115: I/A SPITZE/TIP/POINTE 45°; "QUICK-TIP" 0.35MM; ÖFFNUNG/APRTURE/ORIFICE
• 07630003901054: ASPIRATION SPITZE/TIP/POINTE; GERADE/STRAIGHT/DROITE 0.35MM; ÖFFNUNG/APERTURE/ORIFICE
• 07630003901030: ASPIRATION SPITZE/TIP/POINTE; GERADE/STRAIGHT/DROITE; 0.3MM ÖFFNUNG/APERTURE/ORIFICE
• 07630003901023: I/A HANDSTÜCK TITANO; I/A HAND-PIECE TITANO; MANCHE I/A "QUICK-TIP" TITANO