Definition: Intended For Use In The Insertion Of Suppositories Into The Rectum
| Device Type ID | 2082 |
| Device Name | Applicator For Rectal Suppository |
| Physical State | Plastic, Non-sterile, Single Use Plunger Movably Coupled With A Barrel. |
| Technical Method | Plastic, Non-sterile, Single Use Plunger Movably Coupled With A Barrel. |
| Target Area | Rectal Insertion |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.4730 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OOW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2082 |
| Device | Applicator For Rectal Suppository |
| Product Code | OOW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument And Accessories. |
| CFR Regulation Number | 876.4730 [🔎] |