Ambler Surgical 4135E

GUDID 00190660036157

Venus eye sphere, 22.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1

AMBLER SURGICAL CORP.

Orbital sphere implant

• Primary Device ID: 00190660036157
• NIH Device Record Key: c383383b-9f00-48b4-a3ec-3c941ad896d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambler Surgical
• Version Model Number: 4135E
• Catalog Number: 4135E
• Company DUNS: 015272206
• Company Name: AMBLER SURGICAL CORP.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: +1(888)407-0006
• Email: sales@amblersurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190660036157 [Primary]

FDA Product Code

• HPZ: IMPLANT, EYE SPHERE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-29

On-Brand Devices [Ambler Surgical]

• 00190660036157: Venus eye sphere, 22.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposa
• 00190660036140: Venus eye sphere, 20.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposa
• 00190660036133: Venus eye sphere, 18.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposa
• 00190660036126: Venus eye sphere, 16.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposa
• 00190660036119: Venus eye sphere, 14.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposa
• 00190660036102: Venus eye sphere, 12.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposa
• 00190660036096: Venus eye sphere, 10.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposa
• 00190660036089: Silicone eye sphere, 22.0mm diameter, packaged individually, non-sterile, disposable, box of 1
• 00190660036072: Silicone eye sphere, 20.0mm diameter, packaged individually, non-sterile, disposable, box of 1
• 00190660036010: Silicone eye sphere, 12.0mm diameter, packaged individually, non-sterile, disposable, box of 1
• 00190660018931: Bilateral oval conformer, made of PMMA plastic, small, without holes, packaged individually, non
• 00190660018924: Bilateral oval conformer, made of PMMA plastic, small, with holes, packaged individually, non-st
• 00190660018917: Bilateral oval conformer, made of PMMA plastic, regular, without holes, packaged individually, n
• 00190660018900: Bilateral oval conformer, made of PMMA plastic, regular, with holes, packaged individually, non-
• 00190660194185: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved down 45º
• 00190660194178: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved up 45º,
• 00190660194161: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, straight, 1.5mm
• 00190660194154: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved down 45º
• 00190660194147: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved up 45º,
• 00190660194130: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, straight, 1.2mm
• 00190660194123: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved down 45º
• 00190660194116: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved up 45º,
• 00190660194109: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, straight, 0.7mm
• 00190660194093: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved down 45º
• 00190660194086: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved up 45º,
• 00190660194079: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, straight, 0.4mm
• 00190660194062: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved down 45º
• 00190660194055: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved up 45º,
• 00190660194048: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, straight, 1.5mm
• 00190660194031: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved down 45º
• 00190660194024: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved up 45º,
• 00190660194017: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, straight, 1.2mm
• 00190660194000: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved down 45º
• 00190660193997: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved up 45º,
• 00190660193980: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, straight, 0.7mm
• 00190660193973: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved down 45º
• 00190660193966: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved up 45º,
• 00190660193959: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, straight, 0.4mm
• 00190660193942: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved down 45º,
• 00190660193935: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved up 45º, 1
• 00190660193928: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, straight, 1.5mm w
• 00190660193911: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved down 45º,
• 00190660193904: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved up 45º, 1
• 00190660193898: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, straight, 1.2mm w
• 00190660193881: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved down 45º,
• 00190660193874: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved up 45º, 0
• 00190660193867: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, straight, 0.7mm w
• 00190660193850: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved down 45º,
• 00190660193843: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved up 45º, 0
• 00190660193836: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, straight, 0.4mm w