| Primary Device ID | 00613970002020 |
| NIH Device Record Key | 39e853f8-364a-4e41-81d5-ca775a798b73 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONARCH DISPOSO-SPEC |
| Version Model Number | 200C |
| Catalog Number | 200CC |
| Company DUNS | 007136203 |
| Company Name | MONARCH MOLDING, INC. |
| Device Count | 144 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613970002020 [Primary] |
| GS1 | 10613970002027 [Unit of Use] |
| HIB | Speculum, Vaginal, Nonmetal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-14 |
| 00613970003003 | ONE TIME USE (LARGE) WHITE PLASTIC DISPOSABLE VAGINAL SPECULUM 100/EACH PER CASE- 4/BAGS OF 25 |
| 00613970002020 | CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE MEDIUM - 144 PER CASE EACH IN A POLY BAG |
| 00613970002013 | CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE - MEDIUM - 100 EACH PER CASE 20 - BAGS O |
| 00613970002006 | CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE MEDIUM 100/EACH PER CASE 4 BAGS OF 25/EA |