Ambler Surgical 43-909

GUDID 00190660029494

Bakes common bile duct dilators, 9'', 9.0mm

AMBLER SURGICAL CORP.

Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable Urethral bougie, reusable
Primary Device ID00190660029494
NIH Device Record Key6efca6f9-3d5b-497c-b32a-67b9061fd676
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmbler Surgical
Version Model NumberBakes common bile duct dilators
Catalog Number43-909
Company DUNS015272206
Company NameAMBLER SURGICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com
Phone+1(888)407-0006
Emailsales@amblersurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]
GS100190660029494 [Primary]

FDA Product Code

FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL
FFPDILATOR, RECTAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


[00190660029494]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-12
Device Publish Date2021-01-04

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00190660036102Venus eye sphere, 12.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposa
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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

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