| Primary Device ID | 00192896044487 | 
| NIH Device Record Key | 66f18a3a-3267-4c37-b09a-ac0ac5668dd5 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | FANSLER OPERATING SPECULUM | 
| Version Model Number | 508-338B | 
| Catalog Number | 508-338B | 
| 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 | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00192896044487 [Primary] | 
| FFQ | SPECULUM, RECTAL | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00192896044487]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2018-10-19 | 
| Device Publish Date | 2018-09-18 | 
| 00192896044500 | FANSLER OPERATING SPECULUM SLOTTED TUBE SHORT HANDLE | 
| 00192896044494 | FANSLER OPERATING SPECULUM SLOTTED TUBEEXTRA LONG HANDLE | 
| 00192896044487 | FANSLER OPERATING SPECULUM SLOTTED TUBEEXTRA LONG HANDLE | 
| 00192896044470 | FANSLER OPERATING SPECULUM SLOTTED TUBEEXTRA LONG HANDLE |