| Primary Device ID | 00192896113954 |
| NIH Device Record Key | 4ffbdcbb-4bb0-415a-a390-380065b9409e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wire Speculum |
| Version Model Number | T10-1015 |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, INC. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896113954 [Primary] |
| HNC | Specula, ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113954]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-25 |
| Device Publish Date | 2022-11-17 |
| 00192896089723 | WIRE SPECULUM MINIATURE CLOSED WIRE BLADES |
| 00192896089716 | WIRE SPECULUM MINIATURE V-SHAPED CLOSED WIRE BLADES |
| 00192896089709 | WIRE SPECULUM MINIATURE V-SHAPED OPEN WIRE BLADES |
| 00192896036307 | WIRE SPECULUM WITH THIRD EYELID RETRACTOR CLOSED WIRE BLADES |
| 00192896011885 | WIRE SPECULUM INFANT SIZE CLOSED WIRE BLADES |
| 00192896011878 | WIRE SPECULUM INFANT SIZE CLOSED WIRE BLADES |
| 00192896102729 | Barraquer Wire Speculum 8 Millimeter Closed Round Blade |
| 00192896102712 | Barraquer Wire Speculum 13 Millimeter Closed Round Blades |
| 00192896102668 | Infant Wire Speculum Closed Wire Blades Heavy |
| 00192896104815 | Adjustable Wire Speculum Open Blades Titanium |
| 00192896107083 | Wire Speculum 14 Millimeters Closed Blades 18 Millimeters Spread With Right Third Eyelid Blade |
| 00192896113961 | Wire Speculum Closed Blades 18 Millimeter Spread With Right Third Eyelid Blade Titanium |
| 00192896113954 | Wire Speculum Closed Blades 18 Millimeter Spread With Left Third Eyelid Blade Titanium |
| 00192896115132 | Wire Speculum Closed Blades 18 Millimeter Spread With Left Third Eyelid Blade Titanium |
| 00192896116856 | Wire Speculum With Right 3rd Eyelid Blade Closed Blades Titanium |
| 00192896116849 | Wire Speculum With Left 3rd Eyelid Blade Closed Blades Titanium |