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 ID00190660156084
NIH Device Record Key67ca8da9-7d82-4423-b25c-c4de167afe4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmbler Surgical
Version Model Number5754E
Catalog Number5754E
Company DUNS015272206
Company NameAMBLER SURGICAL CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)407-0006
Emailsales@amblersurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190660156084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKYTonometer, manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190660156084]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-29

On-Brand Devices [Ambler Surgical]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.