Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014718111

FEI Number

1000121355

Entity Name

GI SUPPLY

City/State/Country

Mechanicsburg, PA, US

Establishment Address

5069 Ritter Road, Suite 104, Mechanicsburg, PA 17055, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

GI SUPPLY (Owner Number: 9004474)

Owner / Operator Contact Address

5069 Ritter Road, Suite 104, Mechanicsburg, PA 17055, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253642

PMA Number

N/A

All Registered 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 JADA System Spot Endoscopic Marker JADA System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2023-11-27
NBG	Marker, Colon	Gastroenterology, Urology	Class 2	876.1500	2017-12-15
OQY	Intrauterine Tamponade Balloon	Obstetrics/Gynecology	Class 2	884.4530	2026-05-29
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2014-09-10
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2008-10-17
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2020-07-09
OQY	Intrauterine Tamponade Balloon	Obstetrics/Gynecology	Class 2	884.4530	2026-05-29
NBG	Marker, Colon	Gastroenterology, Urology	Class 2	876.1500	2008-10-17
OQY	Intrauterine Tamponade Balloon	Obstetrics/Gynecology	Class 2	884.4530	2026-05-29

Official Correspondent

Nicole Boser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GI SUPPLY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014718111. Last updated year: 2026. Please use registration number 3014718111 when referencing this establishment in official correspondence.