Ambler Surgical 5754E

GUDID 00190660156084

Schiotz tonometer with inclined scale, manufactured and certified by Gulden Ophthalmic, supplied with case, tables, zero test block and 5.5, 7.5, 10 and 15 gram weights

AMBLER SURGICAL CORP.

Ophthalmic tonometer, manual

• Primary Device ID: 00190660156084
• NIH Device Record Key: 67ca8da9-7d82-4423-b25c-c4de167afe4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambler Surgical
• Version Model Number: 5754E
• Catalog Number: 5754E
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: 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	00190660156084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945541

FDA Product Code

• HKY: Tonometer, manual

Sterilization

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

[00190660156084]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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