| Primary Device ID | 00190660029418 |
| NIH Device Record Key | d5da5aa8-9e90-4936-b1a8-c869d77f4f4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambler Surgical |
| Version Model Number | Bakes common bile duct dilators |
| Catalog Number | 43-913 |
| Company DUNS | 015272206 |
| Company Name | AMBLER SURGICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190660029418 [Primary] |
| FFP | DILATOR, RECTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
[00190660029418]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-12 |
| Device Publish Date | 2021-01-04 |
| 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 |