FDA Registration
Active
🇺🇸 United States
GI SUPPLY
Reg #: 3014718111
·
FEI: 1000121355
·
Expires 2026
Products
6
Proprietary Names
12
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- GI SUPPLY
- Registration Number
- 3014718111
- FEI Number
- 1000121355
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5069 Ritter Road, Suite 104
- City
- Mechanicsburg
- State
- PA
- ZIP
- 17055
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221042
Owner / Operator
- Firm Name
- GI SUPPLY
- Operator Number
- 9004474
- Address
- 5069 Ritter Road, Suite 104
- City
- Mechanicsburg
- State
- PA
- Postal Code
- 17055
- Country
- US
- Correspondent
- Nicole Boser
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2023-11-27 |
| Marker, Colon | NBG | Class 2 | Gastroenterology, Urology | No | 2017-12-15 |
| Intrauterine Tamponade Balloon | OQY | Class 2 | Obstetrics/Gynecology | No | 2026-05-29 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2014-09-10 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2008-10-17 |
| Submucosal Injection Agent | PLL | Class 2 | Gastroenterology, Urology | No | 2020-07-09 |
Proprietary Names
RenovaRP Centesis Pump System
Spot Ex Endoscopic Tattoo
JADA System
RenovaRP Paracentesis Kit
PediaBloc
GeneraBloc
OmniBloc
UltimaBloc
BlueBloc
Oxybloc
EverLift Submucosal Lifting Agent
Spot Endoscopic Marker
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198