| Primary Device ID | 10852073002408 |
| NIH Device Record Key | 0337cf3b-bff7-4d9c-918a-27b74dc98938 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | Uterine Sound |
| Catalog Number | US-01-025 |
| Company DUNS | 130814890 |
| Company Name | C R I |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-556-0349 |
| sales@thomasmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852073002401 [Primary] |
| GS1 | 10852073002408 [Package] Contains: 00852073002401 Package: Box [25 Units] In Commercial Distribution |
| HHM | Sound, Uterine |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-11 |
| 10852073002361 - NA | 2020-07-02 Round Loop, Loop Size: 20mm x 13mm |
| 10852073002378 - NA | 2020-07-02 Round Loop, Loop Size: 20mm x 15mm |
| 10852073002316 - NA | 2020-06-29 Round Loop, Loop Size: 15mm x 15mm |
| 10852073002484 - NA | 2020-06-29 Round Loop, Loop Size: 15mm x 10mm |
| 00852073002814 - NA | 2020-01-21 Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based con |
| 10852073002231 - NA | 2019-05-27 Square Loop, Loop Size: 10mm x 4mm |
| 10852073002248 - NA | 2019-05-27 Round Loop, Loop Size: 5mm x 5mm |
| 10852073002255 - NA | 2019-05-27 Round Loop, Loop Size: 10mm x 5mm |