What is FDA product code FDE?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Colabel · Laparoscopy Kit → Gastroenterology & Urology

Name: Colabel
Brand: Colabel

4manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Anhui (2), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FDE
Manufacturer	City	Province	Registered as	Device types
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Anhui Medical Sterilizing Co., Ltd.	Hefei	Anhui	Contract manufacturer	8

Record

Regulatory record for Colabel
Listed by	Medline Industries, Inc., United States
FDA product code	FDE
Device type	Laparoscopy Kit
Device class	Class 2
Regulation	21 CFR 876.1500
Premarket notification	Exempt
Record published	2020-05-29

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 6

Catalogue Numbers

Catalogue numbers for Colabel
Catalogue number	Size	Status
DYNJ0365463J		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	23,145
Cardinal Health	Cardinal Health 200, LLC	9,245
ACS	American Contract Systems, Inc.	988
Aligned Medical Solutions	Aligned Medical Solutions	156
DeRoyal	Deroyal Industries, Inc.	141
Regard™	ROi CPS LLC	122
Regard™	Resource Optimization & Innovation, L.L.C.	61
Medline	Medline Industries, Inc.	19
Halyard	Avid Medical, Inc.	13
Centurion Medical Products Corp	Medline Industries, Inc.	9
Invenio	GRI Medical & Electronic Technology Co., Ltd.	7
Henry Schein	Henry Schein, Inc.	7

Showing 12 of 17. All products under Laparoscopy Kit

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Colabel
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2025-02-11	Class II	Under Investigation by firm	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.	11,774 units
Medline Industries, LP – Northfield	UDI-DI	2023-05-18	Class II	Device Design	Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.	770147 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Colabel