Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010790919

FEI Number

3010790919

Entity Name

COLOWRAP LLC

City/State/Country

Chapel Hill, NC, US

Establishment Address

7310 Millhouse Rd., Suite 175, Chapel Hill, NC 27516, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ColoWrap LLC (Owner Number: 10047600)

Owner / Operator Contact Address

811 Ninth St., Suite 120, #209, Durham, NC 27705, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ColoWrap Colonoscopy Anti-Looping Compression Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2014-10-09

Official Correspondent

James Hathorn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ColoWrap LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010790919. Last updated year: 2026. Please use registration number 3010790919 when referencing this establishment in official correspondence.