| Primary Device ID | 00192896039186 |
| NIH Device Record Key | 37caabef-da13-4b35-9123-a5fcdf1207e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COTTLE SPECULUM |
| Version Model Number | 465-280 |
| Catalog Number | 465-280 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com |
| Length | 5.5 Inch |
| Length | 5.5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896039186 [Primary] |
| EPY | SPECULUM, ENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896039186]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-05 |
| Device Publish Date | 2018-10-04 |
| 00192896090460 | COTTLE SPECULUM EXTRA DELICATE BLADES BLACK EBONY COATED |
| 00192896039216 | COTTLE SPECULUMEXTRA DELICATE |
| 00192896039193 | COTTLE SPECULUM |
| 00192896039186 | COTTLE SPECULUM |
| 00192896106284 | Cottle Speculum 38 Millimeters |
| 00192896106277 | Cottle Speculum 32 Millimeters |
| 00192896108745 | Cottle Speculum Extra Delicate 50 Millimeters Quantum |