Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGI Supply, Inc.
United States·US-MF-000002609
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 5069, Ritter Road, Mechanicsburg, United States
- Website
- www.gi-supply.com
- —
- —
- [email protected]
- Phone
- 1-800-451-5797
- PRRC Contact
- Scott Moeller
- EUDAMED SRN
- US-MF-000002609
- FDA FEI Number
- 1000121355
- DUNS Number
- 160990313
Catalogue (35)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GeneraBloc Endoscopy Bite Block | GIS-3 | FDA UDI | Class I | Active |
| RenovaRP | GIS-32 | FDA UDI | Class II | Active |
| BlueBloc Endoscopy Bite Block | GIS-1 | FDA UDI | Class I | Active |
| RenovaRP | GIS-30 | FDA UDI | Class II | Active |
| RenovaRP | GIS-31 | FDA UDI | Class II | Active |
| Spot Ex CE Endoscopic Tattoo | GIS-46 | FDA UDI | Class II | Active |
| OmniBloc Endoscopy Bite Block | GIS-11 | FDA UDI | Class I | Active |
| MoonPants XL | GIS-7-XL | FDA UDI | Class I | Active |
| RenovaRP | GIS-29 | FDA UDI | Class II | Active |
| HpOne | GIS-64 | FDA UDI | Class I | Active |
| PediaBloc Endoscopy Bite Block | GIS-2 | FDA UDI | Class I | Active |
| MoonPants SM | GIS-7-SM | FDA UDI | Class I | Active |
| RenovaRP | GIS-27 | FDA UDI | Class II | Active |
| SPOT Endosopic Marker | GIS-44 | FDA UDI | Class II | Active |
| Spot Ex Endoscopic Tattoo | GIS-45 | FDA UDI | Class II | Active |
| SportShorts XL | SL-9XL | FDA UDI | Class I | Active |
| SportShorts SM | SL-9SM | FDA UDI | Class I | Active |
| UltimaBloc Endoscopy Bite Block | GIS-4 | FDA UDI | Class I | Active |
| Large Volume Paracentesis Kit | GIS-28 | FDA UDI | Class II | Unknown |
| RenovaRP | GIS-35 | FDA UDI | Class II | Active |
| SportShorts XS | SL-9XS | FDA UDI | Class I | Active |
| MoonPants Long | GIS-13 | FDA UDI | Class I | Active |
| SportShorts ML | SL-9ML | FDA UDI | Class I | Active |
| Urease | GIS-62-2ML | FDA UDI | Class I | Active |
| MoonPants ML | GIS-7-ML | FDA UDI | Class I | Active |
| Oxy-Bloc | K931044 | FDA 510(k) | Class I | Active |
| Bite Block/Mouthpiece For Endoscopy | K915816 | FDA 510(k) | Class II | Active |
| Renova RP Centesis Pump | K221042 | FDA 510(k) | Class II | Active |
| Runyon Large Volume Paracentesis Kit | K970187 | FDA 510(k) | Class II | Active |
| Gi Supply Biliary Stent | K031360 | FDA 510(k) | Class II | Active |
| Gi Supply Paracentesis Pump | K970186 | FDA 510(k) | Class II | Active |
| Hp-Fast | K944903 | FDA 510(k)FDA UDI | Class I | Active |
| Hp-One | K012411 | FDA 510(k) | Class I | Active |
| EverLift Submucosal Lifting Agent | GIS-55 | EUDAMEDFDA UDI | Class IIa | Active |
| EverLift Submucosal Lifting Agent | GIS-59 | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 28, 2016 | Z-1047-2016 | — | terminated | Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal. |