| Primary Device ID | 00192896013575 |
| NIH Device Record Key | f16a54f5-886b-4b07-a31d-9c89eea125cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BUNGE EVISCERATION SPOON |
| Version Model Number | 12-4602 |
| Catalog Number | 12-4602 |
| 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 |
| Outer Diameter | 7 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896013575 [Primary] |
| HNB | Spoon, ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896013575]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-26 |
| Device Publish Date | 2018-09-18 |
| 00192896013605 | BUNGE EVISCERATION SPOON STRAIGHT HEAD |
| 00192896013599 | BUNGE EVISCERATION SPOON STRAIGHT HEAD |
| 00192896013582 | BUNGE EVISCERATION SPOON STRAIGHT HEAD |
| 00192896013575 | BUNGE EVISCERATION SPOON STRAIGHT HEAD |
| 00192896013568 | BUNGE EVISCERATION SPOON STRAIGHT HEAD |
| 00192896013551 | BUNGE EVISCERATION SPOON STRAIGHT HEAD |