| Primary Device ID | 50618029980279 |
| NIH Device Record Key | d6121f4f-ae93-425f-8f6f-b8bcfbb88d70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stryker Fecal Management System |
| Version Model Number | 700-128 |
| Catalog Number | 700-128 |
| Company DUNS | 054326178 |
| Company Name | SAGE PRODUCTS, LLC |
| 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 | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618029980274 [Primary] |
| GS1 | 50618029980279 [Package] Contains: 00618029980274 Package: case [10 Units] In Commercial Distribution |
| GDS | BAG, STOMAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-15 |
| Device Publish Date | 2023-03-07 |
| 57613327632830 - Sage Multi-Position MATS | 2024-08-20 Sage Multi-Position MATS Mobile Air Transfer System |
| 57613327632878 - Sage TAP LC | 2024-04-03 Sage TAP LC- Lift Compatible Patient Repositioning System |
| 57613327632885 - Sage TAP LC | 2024-04-03 Sage TAP LC- Lift Compatible Patient Repositioning System |
| 50618029791394 - Sage | 2023-10-30 Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis |
| 50618029830246 - Sage | 2023-10-30 Skin Antisepsis and Oral Cleansing |
| 50618029850183 - Sage | 2023-10-30 Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis |
| 50618029830123 - Q-Care Rx | 2023-09-15 Professional Sample- Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse |
| 50618029830215 - Q-Care Rx | 2023-09-15 Professional Sales Sample- Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse |