| Primary Device ID | 00613970018922 |
| NIH Device Record Key | 6b478051-f37c-4ee8-9137-45dc8ac25434 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONARCH DISPOSABLE ANOSCOPE |
| Version Model Number | 1891W |
| Catalog Number | 1891W |
| Company DUNS | 007136203 |
| Company Name | MONARCH MOLDING, INC. |
| Device Count | 100 |
| 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 | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| Phone | 620-767-5115 |
| mmonarch@tctelco.net | |
| 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 | 00613970018922 [Primary] |
| GS1 | 10613970018929 [Unit of Use] |
| KDM | Sigmoidoscope, Rigid, Non-Electrical |
| 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 |
| 00613970018922 | ONE TIME USE 18mm x 90 mm (WHITE) SLOTTED PLASTIC DISPOSABLE ANOSCOPE 100/EACH PER CASE-50/EACH |
| 00613970018915 | ONE TIME USE 18mm x 90mm (CLEAR) SLOTTED PLASTIC DISPOSABLE ANOSCOPE 100/EACH PER CASE-2/BAGS OF |
| 00613970018908 | ONE TIME USE 18mm x 90mm (CLEAR) PLASTIC DISPOSABLE ANOSCOPE 100/EACH PER CASE-2/BAGS OF 50 EACH |
| 00613970014856 | ONE TIME USE 14mm x 85mm (CLEAR) PLASTIC DISPOSABLE ANOSCOPE 100/EACH PER CASE- 2/BAGS OF 50 EAC |