Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1055358

FEI Number

1000110890

Entity Name

GBF INC

City/State/Country

High Point, NC, US

Establishment Address

2427 Penny Rd, High Point, NC 27265, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GBF, INC. (Owner Number: 9005772)

Owner / Operator Contact Address

2427 Penny Rd, High Point, NC 27265, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPECIMEN MAILER & STORAGE TEMPERATURE CONTROLLED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDW	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	Pathology	Class 1	864.3250	2001-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GBF, INC.

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
K913967	Doxtech, Inc.	DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM	1991-10-18

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2244900	GLOBE SCIENTIFIC, LLC	Mahwah, NJ, US
3030708766	VENTURE SOLUTIONS	Grove City, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055358. Last updated year: 2026. Please use registration number 1055358 when referencing this establishment in official correspondence.